Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello all,

I am looking for some guidance on how to proceed.

My workplace is trying to build an implantable device. We do not have a final formulation for the product yet, but are quite close. My CEO has asked me to come up with a plan for the chemical characterization of the device. We are planning to submit a PMA to the FDA.

I have suggested to them that we contract a Clinical Research Organization to conduct testing under ISO 10993-18. They instead want me to evaluate a CRO that does not test to these standards.

My questions are:

1. Should chemical characterization of a device be postponed until we have a device that represents the final product?
2. Is 10993-X the only acceptable standard for the FDA for chemical characterization / biocompatibility?

Thank you in advance for your advice.

​

Hi Anonymous,

There is no definitive answer to your first question, as it depends on a number of things.  The testing does not usually take all that long, so it's not entirely clear why it might be urgent to test the current device.  Are there concerns that the materials could potentially have bad acting constituents, and you want to rule out that possibility before finalizing a design and investing in more testing?  If so, it really should have been tackled when the materials were first selected.

If the chemical characterization testing is truly needed now, it could be possible to use that testing for the final device--if it doesn't differ greatly from the current version.  If the changes are modest, they could potentially be addressed by a subset of the initial testing; that is, just enough to demonstrate chemical equivalence.

Regarding your second question, I'm not aware of standards other than ISO 10993-18 for chemical characterization of medical devices.  There are USP chapters that could potentially be applied, but they are not really geared to implants.  More importantly, it's good to be aware that the current ISO 10993-18 does not include any detail on the types of things FDA would expect to see in chemical characterization testing.  The document is in revision and an FDIS should be coming out for balloting in a couple of months.  It will have considerable more detail, but won't specify everything FDA will want.

I'd be happy to talk with you more about this.  My e-mail is theise@medinstitute.com, and the phone number here is +1 765 463-1633.

Best regards,

Ted

------------------------------
Theodore Heise PhD, RAC
VP Regulatory & Clinical Services
West Lafayette IN
United States
------------------------------

Original Message:
Sent: 11-Feb-2019 10:14
From: Anonymous Member
Subject: Medical Devices - Chemical Characterization

This message was posted by a user wishing to remain anonymous

Hello all,

I am looking for some guidance on how to proceed.

My workplace is trying to build an implantable device. We do not have a final formulation for the product yet, but are quite close. My CEO has asked me to come up with a plan for the chemical characterization of the device. We are planning to submit a PMA to the FDA.

I have suggested to them that we contract a Clinical Research Organization to conduct testing under ISO 10993-18. They instead want me to evaluate a CRO that does not test to these standards.

My questions are:

1. Should chemical characterization of a device be postponed until we have a device that represents the final product?
2. Is 10993-X the only acceptable standard for the FDA for chemical characterization / biocompatibility?

Thank you in advance for your advice.

To my knowledge, 10993 is the only universally accepted Biocompatibility std. Not sure why your company would want you to go for a CRO that does not test to this std.
And I would agree with Ted's response. Do you have a DHF and have you completed performance testing/is in progress? If yes, you may be ready for bio compatibility testing now.

------------------------------
Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States
------------------------------

Original Message:
Sent: 11-Feb-2019 10:14
From: Anonymous Member
Subject: Medical Devices - Chemical Characterization

This message was posted by a user wishing to remain anonymous

Hello all,

I am looking for some guidance on how to proceed.

My workplace is trying to build an implantable device. We do not have a final formulation for the product yet, but are quite close. My CEO has asked me to come up with a plan for the chemical characterization of the device. We are planning to submit a PMA to the FDA.

I have suggested to them that we contract a Clinical Research Organization to conduct testing under ISO 10993-18. They instead want me to evaluate a CRO that does not test to these standards.

My questions are:

1. Should chemical characterization of a device be postponed until we have a device that represents the final product?
2. Is 10993-X the only acceptable standard for the FDA for chemical characterization / biocompatibility?

Thank you in advance for your advice.

IMO, the key question here is why would you want to use a clinical research organization to conduct laboratory testing, instead of a testing laboratory?  ISO 10993-18 (Chemical Characterization of Materials) is about as far away from clinical research as you can get.. Perhaps its just a matter of confusing "CRO" meaning CONTRACT research organization vs. CLINICAL research organization. 

If it is a CONTRACT research organization, then clearly it's the wrong kind of contract research organization.  I have run into startups trying to use laboratories that test other kinds of products for other types of purposes, especially if someone in the startup used to work in another industry and still has contacts there.  (As an example, the startup that was confident the material they planned to use in their Class III implant was "biocompatible" because it had passed biocompatibility testing.  The testing was conducted by a laboratory that primarily served the automotive industry, and therefore was designed to assess materials for use in car seats.)

If it really is a CLINICAL research organization, then this raises other questions, but I'm not sure I want to know.

------------------------------
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: 11-Feb-2019 15:25
From: Vidyalakshmi Jayaraman
Subject: Medical Devices - Chemical Characterization

To my knowledge, 10993 is the only universally accepted Biocompatibility std. Not sure why your company would want you to go for a CRO that does not test to this std.
And I would agree with Ted's response. Do you have a DHF and have you completed performance testing/is in progress? If yes, you may be ready for bio compatibility testing now.

------------------------------
Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States

Original Message:
Sent: 11-Feb-2019 10:14
From: Anonymous Member
Subject: Medical Devices - Chemical Characterization

This message was posted by a user wishing to remain anonymous

Hello all,

I am looking for some guidance on how to proceed.

My workplace is trying to build an implantable device. We do not have a final formulation for the product yet, but are quite close. My CEO has asked me to come up with a plan for the chemical characterization of the device. We are planning to submit a PMA to the FDA.

I have suggested to them that we contract a Clinical Research Organization to conduct testing under ISO 10993-18. They instead want me to evaluate a CRO that does not test to these standards.

My questions are:

1. Should chemical characterization of a device be postponed until we have a device that represents the final product?
2. Is 10993-X the only acceptable standard for the FDA for chemical characterization / biocompatibility?

Thank you in advance for your advice.​

Clinical is probably implied because it is a PMA? But Julie brings up a good point, biocompatibility testing is pre-clinical and must be done by certified labs that specialize in life sciences.

------------------------------
Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States
------------------------------

Original Message:
Sent: 12-Feb-2019 11:39
From: Julie Omohundro
Subject: Medical Devices - Chemical Characterization

IMO, the key question here is why would you want to use a clinical research organization to conduct laboratory testing, instead of a testing laboratory?  ISO 10993-18 (Chemical Characterization of Materials) is about as far away from clinical research as you can get.. Perhaps its just a matter of confusing "CRO" meaning CONTRACT research organization vs. CLINICAL research organization.

If it is a CONTRACT research organization, then clearly it's the wrong kind of contract research organization.  I have run into startups trying to use laboratories that test other kinds of products for other types of purposes, especially if someone in the startup used to work in another industry and still has contacts there.  (As an example, the startup that was confident the material they planned to use in their Class III implant was "biocompatible" because it had passed biocompatibility testing.  The testing was conducted by a laboratory that primarily served the automotive industry, and therefore was designed to assess materials for use in car seats.)

If it really is a CLINICAL research organization, then this raises other questions, but I'm not sure I want to know.

------------------------------
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: 11-Feb-2019 15:25
From: Vidyalakshmi Jayaraman
Subject: Medical Devices - Chemical Characterization

To my knowledge, 10993 is the only universally accepted Biocompatibility std. Not sure why your company would want you to go for a CRO that does not test to this std.
And I would agree with Ted's response. Do you have a DHF and have you completed performance testing/is in progress? If yes, you may be ready for bio compatibility testing now.

------------------------------
Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States

Original Message:
Sent: 11-Feb-2019 10:14
From: Anonymous Member
Subject: Medical Devices - Chemical Characterization

This message was posted by a user wishing to remain anonymous

Hello all,

I am looking for some guidance on how to proceed.

My workplace is trying to build an implantable device. We do not have a final formulation for the product yet, but are quite close. My CEO has asked me to come up with a plan for the chemical characterization of the device. We are planning to submit a PMA to the FDA.

I have suggested to them that we contract a Clinical Research Organization to conduct testing under ISO 10993-18. They instead want me to evaluate a CRO that does not test to these standards.

My questions are:

1. Should chemical characterization of a device be postponed until we have a device that represents the final product?
2. Is 10993-X the only acceptable standard for the FDA for chemical characterization / biocompatibility?

Thank you in advance for your advice.​

Yes, it has also occurred to me that the larger CROs have bioanalytical ​and clinical laboratories.  Perhaps this is the source of the confusion.

Although, you never know...with all the M&A craziness going on, maybe some hungry clinical research organization bought NAMSA by mistake. :)

------------------------------
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: 12-Feb-2019 12:01
From: Vidyalakshmi Jayaraman
Subject: Medical Devices - Chemical Characterization

Clinical is probably implied because it is a PMA? But Julie brings up a good point, biocompatibility testing is pre-clinical and must be done by certified labs that specialize in life sciences.

------------------------------
Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States

Original Message:
Sent: 12-Feb-2019 11:39
From: Julie Omohundro
Subject: Medical Devices - Chemical Characterization

IMO, the key question here is why would you want to use a clinical research organization to conduct laboratory testing, instead of a testing laboratory?  ISO 10993-18 (Chemical Characterization of Materials) is about as far away from clinical research as you can get.. Perhaps its just a matter of confusing "CRO" meaning CONTRACT research organization vs. CLINICAL research organization.

If it is a CONTRACT research organization, then clearly it's the wrong kind of contract research organization.  I have run into startups trying to use laboratories that test other kinds of products for other types of purposes, especially if someone in the startup used to work in another industry and still has contacts there.  (As an example, the startup that was confident the material they planned to use in their Class III implant was "biocompatible" because it had passed biocompatibility testing.  The testing was conducted by a laboratory that primarily served the automotive industry, and therefore was designed to assess materials for use in car seats.)

If it really is a CLINICAL research organization, then this raises other questions, but I'm not sure I want to know.

------------------------------
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: 11-Feb-2019 15:25
From: Vidyalakshmi Jayaraman
Subject: Medical Devices - Chemical Characterization

To my knowledge, 10993 is the only universally accepted Biocompatibility std. Not sure why your company would want you to go for a CRO that does not test to this std.
And I would agree with Ted's response. Do you have a DHF and have you completed performance testing/is in progress? If yes, you may be ready for bio compatibility testing now.

------------------------------
Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States

Original Message:
Sent: 11-Feb-2019 10:14
From: Anonymous Member
Subject: Medical Devices - Chemical Characterization

This message was posted by a user wishing to remain anonymous

Hello all,

I am looking for some guidance on how to proceed.

My workplace is trying to build an implantable device. We do not have a final formulation for the product yet, but are quite close. My CEO has asked me to come up with a plan for the chemical characterization of the device. We are planning to submit a PMA to the FDA.

I have suggested to them that we contract a Clinical Research Organization to conduct testing under ISO 10993-18. They instead want me to evaluate a CRO that does not test to these standards.

My questions are:

1. Should chemical characterization of a device be postponed until we have a device that represents the final product?
2. Is 10993-X the only acceptable standard for the FDA for chemical characterization / biocompatibility?

Thank you in advance for your advice.​

​NAMSA is considered a Medical Research Organization.  We have both CRO capabilities (since 2009) as well as many testing laboratories (since 1967).  I would say that more than a few clients refer to us generally as a CRO even though they use our laboratories!  We do a lot of chemical characterization testing and it is completed per ISO 10993. You can certainly complete the characterization testing on an "incomplete" device.  Then it is all about risk management and change control to determine if/what additional testing would have to be done when the device is completed - most certainly there would be something.  A Biological Risk Assessment would be an excellent place to start to define your path forward.

------------------------------
Jackie Torfin
Vice President, Global QA and Regulatory Compliance
Maple Grove MN
United States
------------------------------

Original Message:
Sent: 12-Feb-2019 13:05
From: Julie Omohundro
Subject: Medical Devices - Chemical Characterization

Yes, it has also occurred to me that the larger CROs have bioanalytical ​and clinical laboratories.  Perhaps this is the source of the confusion.

Although, you never know...with all the M&A craziness going on, maybe some hungry clinical research organization bought NAMSA by mistake. :)

------------------------------
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: 12-Feb-2019 12:01
From: Vidyalakshmi Jayaraman
Subject: Medical Devices - Chemical Characterization

Clinical is probably implied because it is a PMA? But Julie brings up a good point, biocompatibility testing is pre-clinical and must be done by certified labs that specialize in life sciences.

------------------------------
Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States

Original Message:
Sent: 12-Feb-2019 11:39
From: Julie Omohundro
Subject: Medical Devices - Chemical Characterization

IMO, the key question here is why would you want to use a clinical research organization to conduct laboratory testing, instead of a testing laboratory?  ISO 10993-18 (Chemical Characterization of Materials) is about as far away from clinical research as you can get.. Perhaps its just a matter of confusing "CRO" meaning CONTRACT research organization vs. CLINICAL research organization.

If it is a CONTRACT research organization, then clearly it's the wrong kind of contract research organization.  I have run into startups trying to use laboratories that test other kinds of products for other types of purposes, especially if someone in the startup used to work in another industry and still has contacts there.  (As an example, the startup that was confident the material they planned to use in their Class III implant was "biocompatible" because it had passed biocompatibility testing.  The testing was conducted by a laboratory that primarily served the automotive industry, and therefore was designed to assess materials for use in car seats.)

If it really is a CLINICAL research organization, then this raises other questions, but I'm not sure I want to know.

------------------------------
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: 11-Feb-2019 15:25
From: Vidyalakshmi Jayaraman
Subject: Medical Devices - Chemical Characterization

To my knowledge, 10993 is the only universally accepted Biocompatibility std. Not sure why your company would want you to go for a CRO that does not test to this std.
And I would agree with Ted's response. Do you have a DHF and have you completed performance testing/is in progress? If yes, you may be ready for bio compatibility testing now.

------------------------------
Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States

Original Message:
Sent: 11-Feb-2019 10:14
From: Anonymous Member
Subject: Medical Devices - Chemical Characterization

This message was posted by a user wishing to remain anonymous

Hello all,

I am looking for some guidance on how to proceed.

My workplace is trying to build an implantable device. We do not have a final formulation for the product yet, but are quite close. My CEO has asked me to come up with a plan for the chemical characterization of the device. We are planning to submit a PMA to the FDA.

I have suggested to them that we contract a Clinical Research Organization to conduct testing under ISO 10993-18. They instead want me to evaluate a CRO that does not test to these standards.

My questions are:

1. Should chemical characterization of a device be postponed until we have a device that represents the final product?
2. Is 10993-X the only acceptable standard for the FDA for chemical characterization / biocompatibility?

Thank you in advance for your advice.​

Hi Jackie, thanks for chiming in.  Interested to learn about NAMSA's clinical research services.  I'm getting old and out of date anyway, but, in this case, I have more clinical research organizations in my own backyard than I can keep up with, so never had a need to investigate others.  However, this is good to know for companies that are located elsewhere.​

My personal recommendation on device biocompatibility testing is to go out and get someone with some creds (NAMSA has them) to do your initial assessment under 10993-1 (which may be the same as what you are calling a Biological Risk Assessment, or if not, seems like it must be very closely related) and get them to sign it.  Regulators seem to really, really like authoritative opinions on biocompatibility.

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

Original Message:
Sent: 14-Feb-2019 06:50
From: Jackie Torfin
Subject: Medical Devices - Chemical Characterization

​NAMSA is considered a Medical Research Organization.  We have both CRO capabilities (since 2009) as well as many testing laboratories (since 1967).  I would say that more than a few clients refer to us generally as a CRO even though they use our laboratories!  We do a lot of chemical characterization testing and it is completed per ISO 10993. You can certainly complete the characterization testing on an "incomplete" device.  Then it is all about risk management and change control to determine if/what additional testing would have to be done when the device is completed - most certainly there would be something.  A Biological Risk Assessment would be an excellent place to start to define your path forward.

------------------------------
Jackie Torfin
Vice President, Global QA and Regulatory Compliance
Maple Grove MN
United States

Original Message:
Sent: 12-Feb-2019 13:05
From: Julie Omohundro
Subject: Medical Devices - Chemical Characterization

Yes, it has also occurred to me that the larger CROs have bioanalytical ​and clinical laboratories.  Perhaps this is the source of the confusion.

Although, you never know...with all the M&A craziness going on, maybe some hungry clinical research organization bought NAMSA by mistake. :)

------------------------------
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: 12-Feb-2019 12:01
From: Vidyalakshmi Jayaraman
Subject: Medical Devices - Chemical Characterization

Clinical is probably implied because it is a PMA? But Julie brings up a good point, biocompatibility testing is pre-clinical and must be done by certified labs that specialize in life sciences.

------------------------------
Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States

Original Message:
Sent: 12-Feb-2019 11:39
From: Julie Omohundro
Subject: Medical Devices - Chemical Characterization

IMO, the key question here is why would you want to use a clinical research organization to conduct laboratory testing, instead of a testing laboratory?  ISO 10993-18 (Chemical Characterization of Materials) is about as far away from clinical research as you can get.. Perhaps its just a matter of confusing "CRO" meaning CONTRACT research organization vs. CLINICAL research organization.

If it is a CONTRACT research organization, then clearly it's the wrong kind of contract research organization.  I have run into startups trying to use laboratories that test other kinds of products for other types of purposes, especially if someone in the startup used to work in another industry and still has contacts there.  (As an example, the startup that was confident the material they planned to use in their Class III implant was "biocompatible" because it had passed biocompatibility testing.  The testing was conducted by a laboratory that primarily served the automotive industry, and therefore was designed to assess materials for use in car seats.)

If it really is a CLINICAL research organization, then this raises other questions, but I'm not sure I want to know.

------------------------------
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: 11-Feb-2019 15:25
From: Vidyalakshmi Jayaraman
Subject: Medical Devices - Chemical Characterization

To my knowledge, 10993 is the only universally accepted Biocompatibility std. Not sure why your company would want you to go for a CRO that does not test to this std.
And I would agree with Ted's response. Do you have a DHF and have you completed performance testing/is in progress? If yes, you may be ready for bio compatibility testing now.

------------------------------
Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States

Original Message:
Sent: 11-Feb-2019 10:14
From: Anonymous Member
Subject: Medical Devices - Chemical Characterization

This message was posted by a user wishing to remain anonymous

Hello all,

I am looking for some guidance on how to proceed.

My workplace is trying to build an implantable device. We do not have a final formulation for the product yet, but are quite close. My CEO has asked me to come up with a plan for the chemical characterization of the device. We are planning to submit a PMA to the FDA.

I have suggested to them that we contract a Clinical Research Organization to conduct testing under ISO 10993-18. They instead want me to evaluate a CRO that does not test to these standards.

My questions are:

1. Should chemical characterization of a device be postponed until we have a device that represents the final product?
2. Is 10993-X the only acceptable standard for the FDA for chemical characterization / biocompatibility?

Thank you in advance for your advice.​

Thanks Jackie!  I attended the NAMSA presentation at MD&M West on 10993 and Chemical Characterization.  They are indeed experts and you can have complete confidence in the work they do and the certs they provide to support your design, testing, and submission.

Mac

------------------------------
Mac McKeen RAC, MBA
Fellow, Regulatory Science
Maple Grove MN
United States
------------------------------

Original Message:
Sent: 14-Feb-2019 06:50
From: Jackie Torfin
Subject: Medical Devices - Chemical Characterization

​NAMSA is considered a Medical Research Organization.  We have both CRO capabilities (since 2009) as well as many testing laboratories (since 1967).  I would say that more than a few clients refer to us generally as a CRO even though they use our laboratories!  We do a lot of chemical characterization testing and it is completed per ISO 10993. You can certainly complete the characterization testing on an "incomplete" device.  Then it is all about risk management and change control to determine if/what additional testing would have to be done when the device is completed - most certainly there would be something.  A Biological Risk Assessment would be an excellent place to start to define your path forward.

------------------------------
Jackie Torfin
Vice President, Global QA and Regulatory Compliance
Maple Grove MN
United States

Original Message:
Sent: 12-Feb-2019 13:05
From: Julie Omohundro
Subject: Medical Devices - Chemical Characterization

Yes, it has also occurred to me that the larger CROs have bioanalytical ​and clinical laboratories.  Perhaps this is the source of the confusion.

Although, you never know...with all the M&A craziness going on, maybe some hungry clinical research organization bought NAMSA by mistake. :)

------------------------------
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: 12-Feb-2019 12:01
From: Vidyalakshmi Jayaraman
Subject: Medical Devices - Chemical Characterization

Clinical is probably implied because it is a PMA? But Julie brings up a good point, biocompatibility testing is pre-clinical and must be done by certified labs that specialize in life sciences.

------------------------------
Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States

Original Message:
Sent: 12-Feb-2019 11:39
From: Julie Omohundro
Subject: Medical Devices - Chemical Characterization

IMO, the key question here is why would you want to use a clinical research organization to conduct laboratory testing, instead of a testing laboratory?  ISO 10993-18 (Chemical Characterization of Materials) is about as far away from clinical research as you can get.. Perhaps its just a matter of confusing "CRO" meaning CONTRACT research organization vs. CLINICAL research organization.

If it is a CONTRACT research organization, then clearly it's the wrong kind of contract research organization.  I have run into startups trying to use laboratories that test other kinds of products for other types of purposes, especially if someone in the startup used to work in another industry and still has contacts there.  (As an example, the startup that was confident the material they planned to use in their Class III implant was "biocompatible" because it had passed biocompatibility testing.  The testing was conducted by a laboratory that primarily served the automotive industry, and therefore was designed to assess materials for use in car seats.)

If it really is a CLINICAL research organization, then this raises other questions, but I'm not sure I want to know.

------------------------------
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: 11-Feb-2019 15:25
From: Vidyalakshmi Jayaraman
Subject: Medical Devices - Chemical Characterization

To my knowledge, 10993 is the only universally accepted Biocompatibility std. Not sure why your company would want you to go for a CRO that does not test to this std.
And I would agree with Ted's response. Do you have a DHF and have you completed performance testing/is in progress? If yes, you may be ready for bio compatibility testing now.

------------------------------
Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States

Original Message:
Sent: 11-Feb-2019 10:14
From: Anonymous Member
Subject: Medical Devices - Chemical Characterization

This message was posted by a user wishing to remain anonymous

Hello all,

I am looking for some guidance on how to proceed.

My workplace is trying to build an implantable device. We do not have a final formulation for the product yet, but are quite close. My CEO has asked me to come up with a plan for the chemical characterization of the device. We are planning to submit a PMA to the FDA.

I have suggested to them that we contract a Clinical Research Organization to conduct testing under ISO 10993-18. They instead want me to evaluate a CRO that does not test to these standards.

My questions are:

1. Should chemical characterization of a device be postponed until we have a device that represents the final product?
2. Is 10993-X the only acceptable standard for the FDA for chemical characterization / biocompatibility?

Thank you in advance for your advice.​