Regulatory Open Forum

Hi Rashmi,

As you already mentioned, ISO 10993 dictates that the biocompatibility testing must be performed on the finished device (including sterilization) or a representative whenever the device cannot be used as a whole. In the case you use a representative portion of the device you have to justify your selection.
In most of the times, you have to include all the parts of the device using the ratios of the prototype device.
If you do not have a strong justification of your selection, there might be a possibility the authority will ask you to repeat some studies.

Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Manager
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 15-Jan-2019 22:59
From: Rashmi Pillay
Subject: Biocompatibility -representative sample

Hi,

We have received a query from the 3^rd party reviewer for our class II reusable device who has mandated the use of 'finished device' for biocompatibility wherein we have used composite material of the finished device.

 

As per the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Guidance for Industry and Food and Drug Administration Staff"

 

"A. Use of Medical Device in Final Finished Form or Representative Test Article

When biocompatibility testing is necessary, the Agency recommends testing medical devices in the condition that they will be used, whenever possible. This could include final, packaged devices, or as sterilized by an end user, if appropriate. If the medical device in its final finished form cannot be used for biocompatibility testing, a test article (e.g., coupons or "representative components") may be considered. The representative test article should undergo the same manufacturing and sterilization processes, have the same chemical, physical, and surface properties, and have the same ratio of component materials as the medical device in its final finished form."

 

The actual standard also mentions "a) Testing shall be performed on the sterile final product, or representative samples from the final product or

materials processed in the same manner as the final product (including sterilization"

 

Can you confirm if we need to provide a justification , why we haven't used the final sample ( I have no idea why , Project manager took the decision at that time) and if yes , what is the valid justification that would hold good.

 

Thanks & Regards,

 

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

 

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

 

 

 

 

​
Hi Rashmi,

Yes, I would recommend providing a rationale for the testing approach taken.  A potential legitimate reason for use of a representative sample (instead of final, finished device) could be one of timing; that is, a prototype was tested, because the final device was not yet available.

In the rationale, I would suggest quoting the relevant parts of the standard (as you have done in your message), and adding a discussion of why the test articles adequately represent the final, finished device.  Considerations to include in the discussion would be use of same materials, in the same proportions, and processed the same way--especially with respect to sterilization, but also in any other processing (e.g., use of mold release agents).

Hope that helps!

Ted

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

Original Message:
Sent: 15-Jan-2019 22:59
From: Rashmi Pillay
Subject: Biocompatibility -representative sample

Hi,

We have received a query from the 3^rd party reviewer for our class II reusable device who has mandated the use of 'finished device' for biocompatibility wherein we have used composite material of the finished device.

 

As per the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Guidance for Industry and Food and Drug Administration Staff"

 

"A. Use of Medical Device in Final Finished Form or Representative Test Article

When biocompatibility testing is necessary, the Agency recommends testing medical devices in the condition that they will be used, whenever possible. This could include final, packaged devices, or as sterilized by an end user, if appropriate. If the medical device in its final finished form cannot be used for biocompatibility testing, a test article (e.g., coupons or "representative components") may be considered. The representative test article should undergo the same manufacturing and sterilization processes, have the same chemical, physical, and surface properties, and have the same ratio of component materials as the medical device in its final finished form."

 

The actual standard also mentions "a) Testing shall be performed on the sterile final product, or representative samples from the final product or

materials processed in the same manner as the final product (including sterilization"

 

Can you confirm if we need to provide a justification , why we haven't used the final sample ( I have no idea why , Project manager took the decision at that time) and if yes , what is the valid justification that would hold good.

 

Thanks & Regards,

 

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

 

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

 

 

 

 

Hello Rashmi,

Yes you need to justify it and push back, or do it over. I have of companies actually grinding up the whole device which seems crazy if components which will not contact patients or users and are in that final blend. 

Are you following the 2018 version of ISO 10993-1? That version now includes requirements to consider biocomp of parts of a final device broken during shipment which may contact user, or through its lifetime (e.g. degradation),  etc., that you may not have considered before. 

I would consult with a toxicologist to help write that response, if you haven't already, to  determine how or if it could be justified based on intended use. 







------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 15-Jan-2019 22:59
From: Rashmi Pillay
Subject: Biocompatibility -representative sample

Hi,

We have received a query from the 3^rd party reviewer for our class II reusable device who has mandated the use of 'finished device' for biocompatibility wherein we have used composite material of the finished device.

 

As per the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Guidance for Industry and Food and Drug Administration Staff"

 

"A. Use of Medical Device in Final Finished Form or Representative Test Article

When biocompatibility testing is necessary, the Agency recommends testing medical devices in the condition that they will be used, whenever possible. This could include final, packaged devices, or as sterilized by an end user, if appropriate. If the medical device in its final finished form cannot be used for biocompatibility testing, a test article (e.g., coupons or "representative components") may be considered. The representative test article should undergo the same manufacturing and sterilization processes, have the same chemical, physical, and surface properties, and have the same ratio of component materials as the medical device in its final finished form."

 

The actual standard also mentions "a) Testing shall be performed on the sterile final product, or representative samples from the final product or

materials processed in the same manner as the final product (including sterilization"

 

Can you confirm if we need to provide a justification , why we haven't used the final sample ( I have no idea why , Project manager took the decision at that time) and if yes , what is the valid justification that would hold good.

 

Thanks & Regards,

 

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

 

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

 

 

 

 

Rashmi,

The key here will be the assessment of equivalence of the composite material to the "final manufactured product." You would need to establish that the sample underwent all the manufacturing processes (molding, extruding, adhesives, coatings etc). For anything that is different, you would need to establish that the change couldn't impact biocompatibility. For instance, it is sometimes possible to have ADDED materials in your biocompatibility samples (for instance a coating or processing material) that have been removed from final product. Similarly, you might be able to show that, say, adding a saline wash step can only improve biocompatibility. You also shold show that you haven't added materials , or amounts of materials, from the composite sample to really claim equivalence.

From there it gets more complex. Sometimes you can do extracts testing on products from the two different processes/material amounts. If you can show the extracts are the same (at the same levels) you can sometimes rationalize that you don't need to repeat all the other testing. Though there are complexities in some products that make even this hard (for instance products that have breakdown products as they age)

Good luck with this one!

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 15-Jan-2019 22:59
From: Rashmi Pillay
Subject: Biocompatibility -representative sample

Hi,

We have received a query from the 3^rd party reviewer for our class II reusable device who has mandated the use of 'finished device' for biocompatibility wherein we have used composite material of the finished device.

 

As per the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Guidance for Industry and Food and Drug Administration Staff"

 

"A. Use of Medical Device in Final Finished Form or Representative Test Article

When biocompatibility testing is necessary, the Agency recommends testing medical devices in the condition that they will be used, whenever possible. This could include final, packaged devices, or as sterilized by an end user, if appropriate. If the medical device in its final finished form cannot be used for biocompatibility testing, a test article (e.g., coupons or "representative components") may be considered. The representative test article should undergo the same manufacturing and sterilization processes, have the same chemical, physical, and surface properties, and have the same ratio of component materials as the medical device in its final finished form."

 

The actual standard also mentions "a) Testing shall be performed on the sterile final product, or representative samples from the final product or

materials processed in the same manner as the final product (including sterilization"

 

Can you confirm if we need to provide a justification , why we haven't used the final sample ( I have no idea why , Project manager took the decision at that time) and if yes , what is the valid justification that would hold good.

 

Thanks & Regards,

 

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

 

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

 

 

 

 

​Hi Rashmi
Using composite material of a device in lieu of the finished device is allowed in biocompatibility testing as long as the composite material is deemed representative or worse case representation of the patient contacting materials in the finished device.  As you quoted, this is also stated in ISO 10993-1.  Depending on the complexity and the size of the finished device, it is practical to use coupons or representative samples for some tests such as hemocompatibility and implantation, etc.  However, you should provide a rationale for this approach.  Your rationale should include a comparison of ratio of composite materials in the test article versus the final device, sterilization conditions, manufacturing process including use of any coatings, solvents, or mold release agents, etc.

------------------------------
Raji Pidikiti
Lakewood CO
United States
------------------------------

Original Message:
Sent: 15-Jan-2019 22:59
From: Rashmi Pillay
Subject: Biocompatibility -representative sample

Hi,

We have received a query from the 3^rd party reviewer for our class II reusable device who has mandated the use of 'finished device' for biocompatibility wherein we have used composite material of the finished device.

 

As per the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Guidance for Industry and Food and Drug Administration Staff"

 

"A. Use of Medical Device in Final Finished Form or Representative Test Article

When biocompatibility testing is necessary, the Agency recommends testing medical devices in the condition that they will be used, whenever possible. This could include final, packaged devices, or as sterilized by an end user, if appropriate. If the medical device in its final finished form cannot be used for biocompatibility testing, a test article (e.g., coupons or "representative components") may be considered. The representative test article should undergo the same manufacturing and sterilization processes, have the same chemical, physical, and surface properties, and have the same ratio of component materials as the medical device in its final finished form."

 

The actual standard also mentions "a) Testing shall be performed on the sterile final product, or representative samples from the final product or

materials processed in the same manner as the final product (including sterilization"

 

Can you confirm if we need to provide a justification , why we haven't used the final sample ( I have no idea why , Project manager took the decision at that time) and if yes , what is the valid justification that would hold good.

 

Thanks & Regards,

 

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

 

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

 

 

 

 

​Thank you all for your feedback.

The TP reviewer hasn't officially sent me the Deficiency letter but this his point of argument.

"Please understand the FDA guidance is the overriding standard in this case.  The FDA has been very particular about accepting only testing on the final finished device.  Others have tried this approach, FDA has not accepted any rationale or testing on a coupon"

Has anybody tried this approach and was it accepted by the FDA ?

Regards

Rashmi

------------------------------
RashmiAdelaideAustralia
------------------------------

Original Message:
Sent: 16-Jan-2019 11:52
From: Raji Pidikiti
Subject: Biocompatibility -representative sample

​Hi Rashmi
Using composite material of a device in lieu of the finished device is allowed in biocompatibility testing as long as the composite material is deemed representative or worse case representation of the patient contacting materials in the finished device.  As you quoted, this is also stated in ISO 10993-1.  Depending on the complexity and the size of the finished device, it is practical to use coupons or representative samples for some tests such as hemocompatibility and implantation, etc.  However, you should provide a rationale for this approach.  Your rationale should include a comparison of ratio of composite materials in the test article versus the final device, sterilization conditions, manufacturing process including use of any coatings, solvents, or mold release agents, etc.

------------------------------
Raji Pidikiti
Lakewood CO
United States

Original Message:
Sent: 15-Jan-2019 22:59
From: Rashmi Pillay
Subject: Biocompatibility -representative sample

Hi,

We have received a query from the 3^rd party reviewer for our class II reusable device who has mandated the use of 'finished device' for biocompatibility wherein we have used composite material of the finished device.

 

As per the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Guidance for Industry and Food and Drug Administration Staff"

 

"A. Use of Medical Device in Final Finished Form or Representative Test Article

When biocompatibility testing is necessary, the Agency recommends testing medical devices in the condition that they will be used, whenever possible. This could include final, packaged devices, or as sterilized by an end user, if appropriate. If the medical device in its final finished form cannot be used for biocompatibility testing, a test article (e.g., coupons or "representative components") may be considered. The representative test article should undergo the same manufacturing and sterilization processes, have the same chemical, physical, and surface properties, and have the same ratio of component materials as the medical device in its final finished form."

 

The actual standard also mentions "a) Testing shall be performed on the sterile final product, or representative samples from the final product or

materials processed in the same manner as the final product (including sterilization"

 

Can you confirm if we need to provide a justification , why we haven't used the final sample ( I have no idea why , Project manager took the decision at that time) and if yes , what is the valid justification that would hold good.

 

Thanks & Regards,

 

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

 

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

 

 

 

 

Original Message------

​Thank you all for your feedback.

The TP reviewer hasn't officially sent me the Deficiency letter but this his point of argument.

"Please understand the FDA guidance is the overriding standard in this case.  The FDA has been very particular about accepting only testing on the final finished device.  Others have tried this approach, FDA has not accepted any rationale or testing on a coupon"

Has anybody tried this approach and was it accepted by the FDA ?

Regards

Rashmi

------------------------------
RashmiAdelaideAustralia
------------------------------

Rashmi,

One thing I forgot to add previously is that FDA did an internal review of reasons for 510(k) delays and Biocompatability disagreements were the highest item. It is possible your 3rd party has been burned on this and thus is being crazy conservative.

Thus, I'd agree with the other Ginger's comment that you should push them to submit it anyway. Dr. Shuren and Dr. Maisel are personnally interested in this topic (and believe the reviewers often go beyond practicality) and I know of a couple situations in which they have personally intervened to resolve a question like this. If you can get it into FDA (and they open again) you would have this appeal process available.

That said, start with a really tight scientific rationale.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 16-Jan-2019 11:52
From: Raji Pidikiti
Subject: Biocompatibility -representative sample

​Hi Rashmi
Using composite material of a device in lieu of the finished device is allowed in biocompatibility testing as long as the composite material is deemed representative or worse case representation of the patient contacting materials in the finished device.  As you quoted, this is also stated in ISO 10993-1.  Depending on the complexity and the size of the finished device, it is practical to use coupons or representative samples for some tests such as hemocompatibility and implantation, etc.  However, you should provide a rationale for this approach.  Your rationale should include a comparison of ratio of composite materials in the test article versus the final device, sterilization conditions, manufacturing process including use of any coatings, solvents, or mold release agents, etc.

------------------------------
Raji Pidikiti
Lakewood CO
United States

Original Message:
Sent: 15-Jan-2019 22:59
From: Rashmi Pillay
Subject: Biocompatibility -representative sample

Hi,

We have received a query from the 3^rd party reviewer for our class II reusable device who has mandated the use of 'finished device' for biocompatibility wherein we have used composite material of the finished device.

 

As per the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Guidance for Industry and Food and Drug Administration Staff"

 

"A. Use of Medical Device in Final Finished Form or Representative Test Article

When biocompatibility testing is necessary, the Agency recommends testing medical devices in the condition that they will be used, whenever possible. This could include final, packaged devices, or as sterilized by an end user, if appropriate. If the medical device in its final finished form cannot be used for biocompatibility testing, a test article (e.g., coupons or "representative components") may be considered. The representative test article should undergo the same manufacturing and sterilization processes, have the same chemical, physical, and surface properties, and have the same ratio of component materials as the medical device in its final finished form."

 

The actual standard also mentions "a) Testing shall be performed on the sterile final product, or representative samples from the final product or

materials processed in the same manner as the final product (including sterilization"

 

Can you confirm if we need to provide a justification , why we haven't used the final sample ( I have no idea why , Project manager took the decision at that time) and if yes , what is the valid justification that would hold good.

 

Thanks & Regards,

 

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

 

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

 

 

 

 

​​Hi, Rashimi, glad to see you are still with us!

You have gotten plenty of good (and interesting) advice on this matter.  I wanted to add the suggestion that, if the project manager is still with the company, and you have no idea why they chose to test the composite material, you start by finding this out.  If you are lucky, they knew what they were doing.  In that case, just have them write down their explanation and submit it.

I can't say I'm especially optimistic that this will work, but it's easy and costs you nothing, so to me the reasonable first step before you pursue anything more time-consuming and/or that costs money.


------------------------------
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: 15-Jan-2019 22:59
From: Rashmi Pillay
Subject: Biocompatibility -representative sample

Hi,

We have received a query from the 3^rd party reviewer for our class II reusable device who has mandated the use of 'finished device' for biocompatibility wherein we have used composite material of the finished device.

 

As per the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Guidance for Industry and Food and Drug Administration Staff"

 

"A. Use of Medical Device in Final Finished Form or Representative Test Article

When biocompatibility testing is necessary, the Agency recommends testing medical devices in the condition that they will be used, whenever possible. This could include final, packaged devices, or as sterilized by an end user, if appropriate. If the medical device in its final finished form cannot be used for biocompatibility testing, a test article (e.g., coupons or "representative components") may be considered. The representative test article should undergo the same manufacturing and sterilization processes, have the same chemical, physical, and surface properties, and have the same ratio of component materials as the medical device in its final finished form."

 

The actual standard also mentions "a) Testing shall be performed on the sterile final product, or representative samples from the final product or

materials processed in the same manner as the final product (including sterilization"

 

Can you confirm if we need to provide a justification , why we haven't used the final sample ( I have no idea why , Project manager took the decision at that time) and if yes , what is the valid justification that would hold good.

 

Thanks & Regards,

 

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

 

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

 

 

 

 

​Thanks once again for all your valuable feedback, we are using the information of the cleared devices from the original manufacturers of the contact devices , which the 3rd party reviewer is willing to accept , just requiring declaration from the original manufacturers that the contacting devices remain the same as that in the cleared devices and the  510k numbers of the cleared devices . This seems to be the easiest approach rather than  pushing back to use our biocomp data.

Regards,

Rashmi

------------------------------
RashmiAdelaideAustralia
------------------------------

Original Message:
Sent: 17-Jan-2019 14:24
From: Julie Omohundro
Subject: Biocompatibility -representative sample

​​Hi, Rashimi, glad to see you are still with us!

You have gotten plenty of good (and interesting) advice on this matter.  I wanted to add the suggestion that, if the project manager is still with the company, and you have no idea why they chose to test the composite material, you start by finding this out.  If you are lucky, they knew what they were doing.  In that case, just have them write down their explanation and submit it.

I can't say I'm especially optimistic that this will work, but it's easy and costs you nothing, so to me the reasonable first step before you pursue anything more time-consuming and/or that costs money.


------------------------------
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: 15-Jan-2019 22:59
From: Rashmi Pillay
Subject: Biocompatibility -representative sample

Hi,

We have received a query from the 3^rd party reviewer for our class II reusable device who has mandated the use of 'finished device' for biocompatibility wherein we have used composite material of the finished device.

 

As per the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Guidance for Industry and Food and Drug Administration Staff"

 

"A. Use of Medical Device in Final Finished Form or Representative Test Article

When biocompatibility testing is necessary, the Agency recommends testing medical devices in the condition that they will be used, whenever possible. This could include final, packaged devices, or as sterilized by an end user, if appropriate. If the medical device in its final finished form cannot be used for biocompatibility testing, a test article (e.g., coupons or "representative components") may be considered. The representative test article should undergo the same manufacturing and sterilization processes, have the same chemical, physical, and surface properties, and have the same ratio of component materials as the medical device in its final finished form."

 

The actual standard also mentions "a) Testing shall be performed on the sterile final product, or representative samples from the final product or

materials processed in the same manner as the final product (including sterilization"

 

Can you confirm if we need to provide a justification , why we haven't used the final sample ( I have no idea why , Project manager took the decision at that time) and if yes , what is the valid justification that would hold good.

 

Thanks & Regards,

 

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

 

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

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