Regulatory Open Forum

What are the "good" definitions of this term that you have encountered?

By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."

I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.

I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.

Any light shed will be much appreciated.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

In my experience there aren't really any "approved" materials for medical devices. The FDA is always concerned with the effects of your manufacturing process on the material and any combination interactions of materials. However, FDA does recognize a number of material-related Standards, each of which defines a particular grade, composition or formulation of a material.  If you use such a material in your device, FDA will accept that material as suitable from a formulation perspective. However, there may still be questions related to your manufacturing process on the device. 
Many times, a material provider (3M or Dupont are great examples) will have Master Files at the FDA for using their material in a similar or identical intended use. The material provider will allow a company to cite their Master File as evidence of material safety. This allows the material to only reveal the formulation and processing trade secrets to the FDA, who have already reviewed and approved them for use previously. This is the closest thing to "approved" materials as I've experienced.




------------------------------
Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
------------------------------

Original Message:
Sent: 25-Jan-2017 10:44
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

What are the "good" definitions of this term that you have encountered?

By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."

I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.

I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.

Any light shed will be much appreciated.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

I agree with Michael. I have yet to find one!

As a working definition I would offer "a material for which FDA has accepted a DMF when used for intended purposes and within processing ranges specified in that DMF."

Maybe it easier to say "there are none" ... unless the use and processing is exactly as used on a predicate device.

On second thoughts, I feel I am just digging a bigger hole and better stop now!

Neil

------------------------------
Neil Armstrong RAC FRAPS
CEO
MeddiQuest Limited
Cambridgeshire
United Kingdom
------------------------------

Original Message:
Sent: 25-Jan-2017 12:48
From: Michael Nilo
Subject: "FDA-Approved" Materials?

In my experience there aren't really any "approved" materials for medical devices. The FDA is always concerned with the effects of your manufacturing process on the material and any combination interactions of materials. However, FDA does recognize a number of material-related Standards, each of which defines a particular grade, composition or formulation of a material.  If you use such a material in your device, FDA will accept that material as suitable from a formulation perspective. However, there may still be questions related to your manufacturing process on the device. 
Many times, a material provider (3M or Dupont are great examples) will have Master Files at the FDA for using their material in a similar or identical intended use. The material provider will allow a company to cite their Master File as evidence of material safety. This allows the material to only reveal the formulation and processing trade secrets to the FDA, who have already reviewed and approved them for use previously. This is the closest thing to "approved" materials as I've experienced.




------------------------------
Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
------------------------------

Original Message:
Sent: 25-Jan-2017 10:44
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

What are the "good" definitions of this term that you have encountered?

By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."

I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.

I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.

Any light shed will be much appreciated.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Julie

I too am unaware of any materials that are considered "approved" by FDA. The closest I've seen are what I would consider guidelines, such as reg. nr. 872.3710, which list specific metallic alloy classes (but not actual alloys) for use in dental crown.

That being said, vendors of metallic alloys and plastics will often use the term "medical grade" to describe a version of the material in question. This is not a well-defined term. For polymers it usually it means that there are no additives which are known to be problematic for biocompatibility. For metals, it usually means that they are on the list of alloys specified by ASTM in Book 13.01.

 

------------------------------
Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
------------------------------

Original Message:
Sent: 25-Jan-2017 10:44
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

What are the "good" definitions of this term that you have encountered?

By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."

I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.

I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.

Any light shed will be much appreciated.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

I agree.  There isn't really an FDA-approved material list.  Most often, I've seen this used not as FDA-approved materials, but rather materials that FDA has approved.  The thinking is that if a material has been approved in another device then it's been properly assessed and is ok for use.  The problem with that thinking is that FDA approves (or clears) a material for its suitability for a particular application, so using the material in a different use/manner may raise new or different questions with regards to the material's suitability.  Then, there's also the issue that a different manufacturing process could add new concerns for the material's suitability even if it's the same material formulation.  FDA has some information on this in their updated biocompatibility guidance.  Basically, you use history of material use as part of your risk assessment, but it doesn't automatically give you a pass on the material.  Using known materials is a risk mitigation that something could go wrong, but it's generally not enough in its own right.

"Medical grade" is another term that's often misapplied.  First and foremost, there is no universal or official definition of medical grade.  Second, as mentioned, it's often taken to mean that a material is ok for use and doesn't need further biocomp, when that's not true.  

I think the overall take away is that you need to assess materials for a product in their own right, but you can leverage existing data or standards as supporting lines of evidence.  

------------------------------
Bob Laughner MS RAC
Associate Director, Combination Products
MedImmune/AstraZeneca
Gaithersburg MD
United States
------------------------------

Original Message:
Sent: 26-Jan-2017 06:09
From: Jean Bigoney
Subject: "FDA-Approved" Materials?

Julie

I too am unaware of any materials that are considered "approved" by FDA. The closest I've seen are what I would consider guidelines, such as reg. nr. 872.3710, which list specific metallic alloy classes (but not actual alloys) for use in dental crown.

That being said, vendors of metallic alloys and plastics will often use the term "medical grade" to describe a version of the material in question. This is not a well-defined term. For polymers it usually it means that there are no additives which are known to be problematic for biocompatibility. For metals, it usually means that they are on the list of alloys specified by ASTM in Book 13.01.

ASTM F75 Cast Cobalt-Chromium-Molybdenum Alloy for Surgical Implant Applications

ASTM F961 Cobalt-Nickel-Chromium-Molybdenum Alloy Forgings for Surgical Implant Applications

ASTM F799 Thermomechanically Processed Cobalt-Chromium-Molybdenum Alloy for Surgical Implants

ASTM F562 Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy for Surgical Implant Applications

ASTM F1058 Wrought Cobalt-Chromium-Nickel-Molybdenum-Iron Alloy for Surgical Implant Applications

ASTM F563 Wrought Cobalt-Nickel-Chromium-Molybdenum-Tungsten-Iron Alloy for Surgical Implant Applications

ASTM F1108 Ti6Al4V Alloy Castings for Surgical Implant Applications 

ASTM F620 Titanium 6Al-4V ELI Forgings for Surgical Implant Applications 

ASTM F67 Unalloyed Titanium for Surgical Implant Applications 

ASTM F1341 Unalloyed Titanium Wire for Surgical Implant Applications 

ASTM F136 Wrought Titanium 6Al-4V ELI Alloy for Surgical Implant Applications

ASTM F1472 Wrought Titanium 6Al-4V Alloy for Surgical Implant Applications

ASTM F1295 Wrought Titanium 6 Aluminum-7 Niobium Alloy for Surgical Implant Applications

ASTM F138 Stainless Steel Bar and Wire for Surgical Implants (Special Quality)

ASTM F139 Stainless Steel Sheet and Strip for Surgical Implants (Special Quality)

ASTM F899 Stainless Steel Billet, Bar and Wire for Surgical Instruments

ASTM F745 Stainless Steel for Cast and Solution Annealed Surgical Implant Applications

ASTM F621 Stainless Steel Forgings Surgical Implants

In addition there is a specification for tantalum

ASTM F560 Unalloyed Tantalum for Surgical Implant Applications

For cardiovascular devices, shape memory alloys based on nickel-titanium or "Nitinol" are widely used.

ASTM F2063 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

ASTM F2633 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants

Eager potential 510(k) applicants often interpret the vague term "medical grade" to mean "no biocompatibility studies needed." In practice what I have seen is that relying on materials with a history in the application is route to clearance with the fewest speed bumps..

 

------------------------------
Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
------------------------------

Original Message:
Sent: 25-Jan-2017 10:44
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

What are the "good" definitions of this term that you have encountered?

By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."

I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.

I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.

Any light shed will be much appreciated.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Julie,
I believe you may be referring to the FDA inactive ingredient list that lists excipients used in approved products and the amount of excipient.  Here is a link to the site:  Inactive Ingredient Search for Approved Drug Products. 
Search by ingredient then find a product similar to yours (tablet, cream, transdermal, etc.).  The amount of excipient approved is provided in the list.  If your product contains more amount of the excipient than what FDA has approved then you may need to do additional safety studies to prove that the ingredient is safe for your development product.  


------------------------------
Darlene O'Banion
RegulatoryQS
San Jose CA
USA
------------------------------

Original Message:
Sent: 25-Jan-2017 10:44
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

What are the "good" definitions of this term that you have encountered?

By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."

I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.

I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.

Any light shed will be much appreciated.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

I appreciate all the responses.  That's what I thought all these years, but then, I hadn't ever done anything with dental devices, which include:

§ 872.3670 - Resin impression tray material.
§ 872.3275 - Dental cement.
 
And others. FDA refers to them as "devices," but as far as I can tell, they pretty much are, in fact, materials.  There is even a 510(k) guidance for the resin. 

Anyone here see it differently?  There is of course the matter of intended use, which is, I would guess, why FDA sees them as medical devices, rather than materials. But if an engineer tells me he's using a material that is "FDA-approved" for the same intended use, is he really wrong in any way?  Well, except for reg-geeky detail of it having been "cleared" rather than "approved"?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 25-Jan-2017 10:44
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

What are the "good" definitions of this term that you have encountered?

By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."

I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.

I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.

Any light shed will be much appreciated.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Julie

Dental medical devices are different from most conventional medical devices in that they are intended to be modified / customized by the end user, namely the dentist. There are implants and abutments that are manufactured and intended to be used as-manufactured. Then there are blanks which are sold and intended to be custom machined by a cleared device, as well as blanks which are intended to be modified "chairside" by the dental practitioner. From there it is a slippery slope from the blanks that vaguely resemble the finished device to the raw material which in no way does so, and is intended to be cast or otherwise formed as-needed - which the dentist can only judge when the patient is being treated..

I can understand how an engineer would look at the materials commonly used in dental applications and come to the conclusion that because PEEK appears to be the material of choice for customizable healing caps and POM-C is the material of choice for customizable UCLA-type abutments, etc. that FDA has somehow "approved" these materials.

------------------------------
Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
------------------------------

Original Message:
Sent: 26-Jan-2017 14:54
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

I appreciate all the responses.  That's what I thought all these years, but then, I hadn't ever done anything with dental devices, which include:

§ 872.3670 - Resin impression tray material.
§ 872.3275 - Dental cement.
 
And others. FDA refers to them as "devices," but as far as I can tell, they pretty much are, in fact, materials.  There is even a 510(k) guidance for the resin. 

Anyone here see it differently?  There is of course the matter of intended use, which is, I would guess, why FDA sees them as medical devices, rather than materials. But if an engineer tells me he's using a material that is "FDA-approved" for the same intended use, is he really wrong in any way?  Well, except for reg-geeky detail of it having been "cleared" rather than "approved"?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 25-Jan-2017 10:44
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

What are the "good" definitions of this term that you have encountered?

By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."

I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.

I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.

Any light shed will be much appreciated.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Julie,
What Jean said is correct for these devices. Because the end user ultimately modifies or applies the resin/cement, the material becomes the regulated component. Ultimately, these resins are complex formulations and the percentages of each component are reviewed. The processing and packaging is also considered so that even two identical formulations may not result in the same regulatory conclusion. The FDA is not clearing (510k devices) the material straight away, it is clearing the device. It just so happens that the lion's share of the device is just the material formulation.

------------------------------
Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
------------------------------

Original Message:
Sent: 26-Jan-2017 20:37
From: Jean Bigoney
Subject: "FDA-Approved" Materials?

Julie

Dental medical devices are different from most conventional medical devices in that they are intended to be modified / customized by the end user, namely the dentist. There are implants and abutments that are manufactured and intended to be used as-manufactured. Then there are blanks which are sold and intended to be custom machined by a cleared device, as well as blanks which are intended to be modified "chairside" by the dental practitioner. From there it is a slippery slope from the blanks that vaguely resemble the finished device to the raw material which in no way does so, and is intended to be cast or otherwise formed as-needed - which the dentist can only judge when the patient is being treated..

I can understand how an engineer would look at the materials commonly used in dental applications and come to the conclusion that because PEEK appears to be the material of choice for customizable healing caps and POM-C is the material of choice for customizable UCLA-type abutments, etc. that FDA has somehow "approved" these materials.

------------------------------
Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
------------------------------

Original Message:
Sent: 26-Jan-2017 14:54
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

I appreciate all the responses.  That's what I thought all these years, but then, I hadn't ever done anything with dental devices, which include:

§ 872.3670 - Resin impression tray material.
§ 872.3275 - Dental cement.
 
And others. FDA refers to them as "devices," but as far as I can tell, they pretty much are, in fact, materials.  There is even a 510(k) guidance for the resin. 

Anyone here see it differently?  There is of course the matter of intended use, which is, I would guess, why FDA sees them as medical devices, rather than materials. But if an engineer tells me he's using a material that is "FDA-approved" for the same intended use, is he really wrong in any way?  Well, except for reg-geeky detail of it having been "cleared" rather than "approved"?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 25-Jan-2017 10:44
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

What are the "good" definitions of this term that you have encountered?

By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."

I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.

I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.

Any light shed will be much appreciated.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Dear Julie,

I am not very well experienced person like you and others, but my 6 year regulatory profession, what I understand with pharmaceutical equipments, container-closure system, polyethylne bags, etc. neumorous components deliver the same message "FDA-approved materials". Indirectly that all are FCS (Food Contact Substances) and GRAS (Generally Recognised As Safe). USFDA always ask for Food Grade Certification to ensure that if they are in contact of drugs, still drugs are safe and effective.

The below link is for your ready reference, if I understand your question correctly:

https://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/RegulatoryStatusFoodContactMaterial/ucm120771.htm


------------------------------
Gaurang Bhavsar
Edison NJ
United States
------------------------------

Original Message:
Sent: 27-Jan-2017 13:10
From: Michael Nilo
Subject: "FDA-Approved" Materials?

Julie,
What Jean said is correct for these devices. Because the end user ultimately modifies or applies the resin/cement, the material becomes the regulated component. Ultimately, these resins are complex formulations and the percentages of each component are reviewed. The processing and packaging is also considered so that even two identical formulations may not result in the same regulatory conclusion. The FDA is not clearing (510k devices) the material straight away, it is clearing the device. It just so happens that the lion's share of the device is just the material formulation.

------------------------------
Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
------------------------------

Original Message:
Sent: 26-Jan-2017 20:37
From: Jean Bigoney
Subject: "FDA-Approved" Materials?

Julie

Dental medical devices are different from most conventional medical devices in that they are intended to be modified / customized by the end user, namely the dentist. There are implants and abutments that are manufactured and intended to be used as-manufactured. Then there are blanks which are sold and intended to be custom machined by a cleared device, as well as blanks which are intended to be modified "chairside" by the dental practitioner. From there it is a slippery slope from the blanks that vaguely resemble the finished device to the raw material which in no way does so, and is intended to be cast or otherwise formed as-needed - which the dentist can only judge when the patient is being treated..

I can understand how an engineer would look at the materials commonly used in dental applications and come to the conclusion that because PEEK appears to be the material of choice for customizable healing caps and POM-C is the material of choice for customizable UCLA-type abutments, etc. that FDA has somehow "approved" these materials.

------------------------------
Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
------------------------------

Original Message:
Sent: 26-Jan-2017 14:54
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

I appreciate all the responses.  That's what I thought all these years, but then, I hadn't ever done anything with dental devices, which include:

§ 872.3670 - Resin impression tray material.
§ 872.3275 - Dental cement.
 
And others. FDA refers to them as "devices," but as far as I can tell, they pretty much are, in fact, materials.  There is even a 510(k) guidance for the resin. 

Anyone here see it differently?  There is of course the matter of intended use, which is, I would guess, why FDA sees them as medical devices, rather than materials. But if an engineer tells me he's using a material that is "FDA-approved" for the same intended use, is he really wrong in any way?  Well, except for reg-geeky detail of it having been "cleared" rather than "approved"?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 25-Jan-2017 10:44
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

What are the "good" definitions of this term that you have encountered?

By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."

I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.

I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.

Any light shed will be much appreciated.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Hi, Julie,

If you are looking to show biocompatibility of a material for a submission please see the FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".


------------------------------
John Minier, RAC
Director/Consultant
Minier Medical Device Consulting
john@johnminier.com
Highland Mills, NY
United States
------------------------------

Original Message:
Sent: 02-Mar-2017 22:20
From: Gaurang Bhavsar
Subject: "FDA-Approved" Materials?

Dear Julie,

I am not very well experienced person like you and others, but my 6 year regulatory profession, what I understand with pharmaceutical equipments, container-closure system, polyethylne bags, etc. neumorous components deliver the same message "FDA-approved materials". Indirectly that all are FCS (Food Contact Substances) and GRAS (Generally Recognised As Safe). USFDA always ask for Food Grade Certification to ensure that if they are in contact of drugs, still drugs are safe and effective.

The below link is for your ready reference, if I understand your question correctly:

https://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/RegulatoryStatusFoodContactMaterial/ucm120771.htm


------------------------------
Gaurang Bhavsar
Edison NJ
United States
------------------------------

Original Message:
Sent: 27-Jan-2017 13:10
From: Michael Nilo
Subject: "FDA-Approved" Materials?

Julie,
What Jean said is correct for these devices. Because the end user ultimately modifies or applies the resin/cement, the material becomes the regulated component. Ultimately, these resins are complex formulations and the percentages of each component are reviewed. The processing and packaging is also considered so that even two identical formulations may not result in the same regulatory conclusion. The FDA is not clearing (510k devices) the material straight away, it is clearing the device. It just so happens that the lion's share of the device is just the material formulation.

------------------------------
Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
------------------------------

Original Message:
Sent: 26-Jan-2017 20:37
From: Jean Bigoney
Subject: "FDA-Approved" Materials?

Julie

Dental medical devices are different from most conventional medical devices in that they are intended to be modified / customized by the end user, namely the dentist. There are implants and abutments that are manufactured and intended to be used as-manufactured. Then there are blanks which are sold and intended to be custom machined by a cleared device, as well as blanks which are intended to be modified "chairside" by the dental practitioner. From there it is a slippery slope from the blanks that vaguely resemble the finished device to the raw material which in no way does so, and is intended to be cast or otherwise formed as-needed - which the dentist can only judge when the patient is being treated..

I can understand how an engineer would look at the materials commonly used in dental applications and come to the conclusion that because PEEK appears to be the material of choice for customizable healing caps and POM-C is the material of choice for customizable UCLA-type abutments, etc. that FDA has somehow "approved" these materials.

------------------------------
Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
------------------------------

Original Message:
Sent: 26-Jan-2017 14:54
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

I appreciate all the responses.  That's what I thought all these years, but then, I hadn't ever done anything with dental devices, which include:

§ 872.3670 - Resin impression tray material.
§ 872.3275 - Dental cement.
 
And others. FDA refers to them as "devices," but as far as I can tell, they pretty much are, in fact, materials.  There is even a 510(k) guidance for the resin. 

Anyone here see it differently?  There is of course the matter of intended use, which is, I would guess, why FDA sees them as medical devices, rather than materials. But if an engineer tells me he's using a material that is "FDA-approved" for the same intended use, is he really wrong in any way?  Well, except for reg-geeky detail of it having been "cleared" rather than "approved"?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 25-Jan-2017 10:44
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

What are the "good" definitions of this term that you have encountered?

By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."

I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.

I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.

Any light shed will be much appreciated.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

"All men are ignorant, just on different subjects." - Mark Twain
 
I'm sure you know much more about food regulation than I do!

I have been thinking of this question from a medical device perspective.  From that perspective, I would interpret "FDA-approved" to mean that FDA has reviewed the data and approved the material for a particular intended use.  I can't see FDA ever approving a material for use in devices independent of intended use.

From what little I know about GRAS ingredients, I can see them being described as "FDA-approved."  I can also see them being described as the opposite of FDA-approved, given that, as I understand it, the important thing about GRAS ingredients is that they are exempt from FDA pre-market review and approval.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 02-Mar-2017 22:20
From: Gaurang Bhavsar
Subject: "FDA-Approved" Materials?

Dear Julie,

I am not very well experienced person like you and others, but my 6 year regulatory profession, what I understand with pharmaceutical equipments, container-closure system, polyethylne bags, etc. neumorous components deliver the same message "FDA-approved materials". Indirectly that all are FCS (Food Contact Substances) and GRAS (Generally Recognised As Safe). USFDA always ask for Food Grade Certification to ensure that if they are in contact of drugs, still drugs are safe and effective.

The below link is for your ready reference, if I understand your question correctly:

https://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/RegulatoryStatusFoodContactMaterial/ucm120771.htm


------------------------------
Gaurang Bhavsar
Edison NJ
United States
------------------------------

Original Message:
Sent: 27-Jan-2017 13:10
From: Michael Nilo
Subject: "FDA-Approved" Materials?

Julie,
What Jean said is correct for these devices. Because the end user ultimately modifies or applies the resin/cement, the material becomes the regulated component. Ultimately, these resins are complex formulations and the percentages of each component are reviewed. The processing and packaging is also considered so that even two identical formulations may not result in the same regulatory conclusion. The FDA is not clearing (510k devices) the material straight away, it is clearing the device. It just so happens that the lion's share of the device is just the material formulation.

------------------------------
Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
------------------------------

Original Message:
Sent: 26-Jan-2017 20:37
From: Jean Bigoney
Subject: "FDA-Approved" Materials?

Julie

Dental medical devices are different from most conventional medical devices in that they are intended to be modified / customized by the end user, namely the dentist. There are implants and abutments that are manufactured and intended to be used as-manufactured. Then there are blanks which are sold and intended to be custom machined by a cleared device, as well as blanks which are intended to be modified "chairside" by the dental practitioner. From there it is a slippery slope from the blanks that vaguely resemble the finished device to the raw material which in no way does so, and is intended to be cast or otherwise formed as-needed - which the dentist can only judge when the patient is being treated..

I can understand how an engineer would look at the materials commonly used in dental applications and come to the conclusion that because PEEK appears to be the material of choice for customizable healing caps and POM-C is the material of choice for customizable UCLA-type abutments, etc. that FDA has somehow "approved" these materials.

------------------------------
Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
------------------------------

Original Message:
Sent: 26-Jan-2017 14:54
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

I appreciate all the responses.  That's what I thought all these years, but then, I hadn't ever done anything with dental devices, which include:

§ 872.3670 - Resin impression tray material.
§ 872.3275 - Dental cement.
 
And others. FDA refers to them as "devices," but as far as I can tell, they pretty much are, in fact, materials.  There is even a 510(k) guidance for the resin. 

Anyone here see it differently?  There is of course the matter of intended use, which is, I would guess, why FDA sees them as medical devices, rather than materials. But if an engineer tells me he's using a material that is "FDA-approved" for the same intended use, is he really wrong in any way?  Well, except for reg-geeky detail of it having been "cleared" rather than "approved"?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 25-Jan-2017 10:44
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

What are the "good" definitions of this term that you have encountered?

By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."

I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.

I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.

Any light shed will be much appreciated.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Color-additives are "approved" by FDA for use in certain medical devices and FDA publishes a list of those additives.
From FDA website:

CFR Part 73 - Listing of Color Additives Exempt from Certification
These regulations list the FDA-approved color additives that are exempt from FDA’s certification process. The regulations state the permitted uses, specifications, and restrictions that apply to each of these color additives.

21 CFR Part 74 - Listing of Color Additives Subject to Certification
These regulations list the FDA-approved color additives that are subject to FDA’s certification process. The regulations state the permitted uses, specifications, and restrictions that apply to each of these color additives.

------------------------------
Marcia Arentz RAC
Associate Director Regulatory Affairs
Eli Lilly and Company
Indianapolis IN
United States
------------------------------

Original Message:
Sent: 05-Mar-2017 19:42
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

"All men are ignorant, just on different subjects." - Mark Twain
 
I'm sure you know much more about food regulation than I do!

I have been thinking of this question from a medical device perspective.  From that perspective, I would interpret "FDA-approved" to mean that FDA has reviewed the data and approved the material for a particular intended use.  I can't see FDA ever approving a material for use in devices independent of intended use.

From what little I know about GRAS ingredients, I can see them being described as "FDA-approved."  I can also see them being described as the opposite of FDA-approved, given that, as I understand it, the important thing about GRAS ingredients is that they are exempt from FDA pre-market review and approval.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 02-Mar-2017 22:20
From: Gaurang Bhavsar
Subject: "FDA-Approved" Materials?

Dear Julie,

I am not very well experienced person like you and others, but my 6 year regulatory profession, what I understand with pharmaceutical equipments, container-closure system, polyethylne bags, etc. neumorous components deliver the same message "FDA-approved materials". Indirectly that all are FCS (Food Contact Substances) and GRAS (Generally Recognised As Safe). USFDA always ask for Food Grade Certification to ensure that if they are in contact of drugs, still drugs are safe and effective.

The below link is for your ready reference, if I understand your question correctly:

https://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/RegulatoryStatusFoodContactMaterial/ucm120771.htm


------------------------------
Gaurang Bhavsar
Edison NJ
United States
------------------------------

Original Message:
Sent: 27-Jan-2017 13:10
From: Michael Nilo
Subject: "FDA-Approved" Materials?

Julie,
What Jean said is correct for these devices. Because the end user ultimately modifies or applies the resin/cement, the material becomes the regulated component. Ultimately, these resins are complex formulations and the percentages of each component are reviewed. The processing and packaging is also considered so that even two identical formulations may not result in the same regulatory conclusion. The FDA is not clearing (510k devices) the material straight away, it is clearing the device. It just so happens that the lion's share of the device is just the material formulation.

------------------------------
Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
------------------------------

Original Message:
Sent: 26-Jan-2017 20:37
From: Jean Bigoney
Subject: "FDA-Approved" Materials?

Julie

Dental medical devices are different from most conventional medical devices in that they are intended to be modified / customized by the end user, namely the dentist. There are implants and abutments that are manufactured and intended to be used as-manufactured. Then there are blanks which are sold and intended to be custom machined by a cleared device, as well as blanks which are intended to be modified "chairside" by the dental practitioner. From there it is a slippery slope from the blanks that vaguely resemble the finished device to the raw material which in no way does so, and is intended to be cast or otherwise formed as-needed - which the dentist can only judge when the patient is being treated..

I can understand how an engineer would look at the materials commonly used in dental applications and come to the conclusion that because PEEK appears to be the material of choice for customizable healing caps and POM-C is the material of choice for customizable UCLA-type abutments, etc. that FDA has somehow "approved" these materials.

------------------------------
Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
------------------------------

Original Message:
Sent: 26-Jan-2017 14:54
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

I appreciate all the responses.  That's what I thought all these years, but then, I hadn't ever done anything with dental devices, which include:

§ 872.3670 - Resin impression tray material.
§ 872.3275 - Dental cement.
 
And others. FDA refers to them as "devices," but as far as I can tell, they pretty much are, in fact, materials.  There is even a 510(k) guidance for the resin. 

Anyone here see it differently?  There is of course the matter of intended use, which is, I would guess, why FDA sees them as medical devices, rather than materials. But if an engineer tells me he's using a material that is "FDA-approved" for the same intended use, is he really wrong in any way?  Well, except for reg-geeky detail of it having been "cleared" rather than "approved"?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 25-Jan-2017 10:44
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

What are the "good" definitions of this term that you have encountered?

By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."

I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.

I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.

Any light shed will be much appreciated.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Thanks for this additional information, Marcia.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 09-Mar-2017 15:38
From: Marcia Arentz
Subject: "FDA-Approved" Materials?

Color-additives are "approved" by FDA for use in certain medical devices and FDA publishes a list of those additives.
From FDA website:

CFR Part 73 - Listing of Color Additives Exempt from Certification
These regulations list the FDA-approved color additives that are exempt from FDA’s certification process. The regulations state the permitted uses, specifications, and restrictions that apply to each of these color additives.

21 CFR Part 74 - Listing of Color Additives Subject to Certification
These regulations list the FDA-approved color additives that are subject to FDA’s certification process. The regulations state the permitted uses, specifications, and restrictions that apply to each of these color additives.

------------------------------
Marcia Arentz RAC
Associate Director Regulatory Affairs
Eli Lilly and Company
Indianapolis IN
United States
------------------------------

Original Message:
Sent: 05-Mar-2017 19:42
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

"All men are ignorant, just on different subjects." - Mark Twain
 
I'm sure you know much more about food regulation than I do!

I have been thinking of this question from a medical device perspective.  From that perspective, I would interpret "FDA-approved" to mean that FDA has reviewed the data and approved the material for a particular intended use.  I can't see FDA ever approving a material for use in devices independent of intended use.

From what little I know about GRAS ingredients, I can see them being described as "FDA-approved."  I can also see them being described as the opposite of FDA-approved, given that, as I understand it, the important thing about GRAS ingredients is that they are exempt from FDA pre-market review and approval.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 02-Mar-2017 22:20
From: Gaurang Bhavsar
Subject: "FDA-Approved" Materials?

Dear Julie,

I am not very well experienced person like you and others, but my 6 year regulatory profession, what I understand with pharmaceutical equipments, container-closure system, polyethylne bags, etc. neumorous components deliver the same message "FDA-approved materials". Indirectly that all are FCS (Food Contact Substances) and GRAS (Generally Recognised As Safe). USFDA always ask for Food Grade Certification to ensure that if they are in contact of drugs, still drugs are safe and effective.

The below link is for your ready reference, if I understand your question correctly:

https://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/RegulatoryStatusFoodContactMaterial/ucm120771.htm


------------------------------
Gaurang Bhavsar
Edison NJ
United States
------------------------------

Original Message:
Sent: 27-Jan-2017 13:10
From: Michael Nilo
Subject: "FDA-Approved" Materials?

Julie,
What Jean said is correct for these devices. Because the end user ultimately modifies or applies the resin/cement, the material becomes the regulated component. Ultimately, these resins are complex formulations and the percentages of each component are reviewed. The processing and packaging is also considered so that even two identical formulations may not result in the same regulatory conclusion. The FDA is not clearing (510k devices) the material straight away, it is clearing the device. It just so happens that the lion's share of the device is just the material formulation.

------------------------------
Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
------------------------------

Original Message:
Sent: 26-Jan-2017 20:37
From: Jean Bigoney
Subject: "FDA-Approved" Materials?

Julie

Dental medical devices are different from most conventional medical devices in that they are intended to be modified / customized by the end user, namely the dentist. There are implants and abutments that are manufactured and intended to be used as-manufactured. Then there are blanks which are sold and intended to be custom machined by a cleared device, as well as blanks which are intended to be modified "chairside" by the dental practitioner. From there it is a slippery slope from the blanks that vaguely resemble the finished device to the raw material which in no way does so, and is intended to be cast or otherwise formed as-needed - which the dentist can only judge when the patient is being treated..

I can understand how an engineer would look at the materials commonly used in dental applications and come to the conclusion that because PEEK appears to be the material of choice for customizable healing caps and POM-C is the material of choice for customizable UCLA-type abutments, etc. that FDA has somehow "approved" these materials.

------------------------------
Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
------------------------------

Original Message:
Sent: 26-Jan-2017 14:54
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

I appreciate all the responses.  That's what I thought all these years, but then, I hadn't ever done anything with dental devices, which include:

§ 872.3670 - Resin impression tray material.
§ 872.3275 - Dental cement.
 
And others. FDA refers to them as "devices," but as far as I can tell, they pretty much are, in fact, materials.  There is even a 510(k) guidance for the resin. 

Anyone here see it differently?  There is of course the matter of intended use, which is, I would guess, why FDA sees them as medical devices, rather than materials. But if an engineer tells me he's using a material that is "FDA-approved" for the same intended use, is he really wrong in any way?  Well, except for reg-geeky detail of it having been "cleared" rather than "approved"?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 25-Jan-2017 10:44
From: Julie Omohundro
Subject: "FDA-Approved" Materials?

What are the "good" definitions of this term that you have encountered?

By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."

I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.

I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.

Any light shed will be much appreciated.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------