Regulatory Open Forum

Years ago, this was easier to rationalize but in recent years, using representative material over a finished device sample is almost never acceptable. Current practice is to test your worst case representative sample of the finished devices. If there is only a particular part of the finished device that is patient-contacting, you might be able to test that in its finished state but you'd need a sound justification to explain why only that part is applicable/tested. I've never used a template for this so unfortunately, I don't have one to share. (In addition to patient contact, take user contact into consideration as well.)

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Ruthanne Vendy RAC
Senior Principal Specialist
United States
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Original Message:
Sent: 11-May-2019 09:09
From: Rashmi Pillay
Subject: Biocompatibility declaration using representative sample

Hi,

 

Has anybody done a 510(k) submission using representative sample for testing instead of final device ?

 

I recently checked on the approach of representative sample testing with the FDA , described our device wherein the direct contact portion was very small and the final samples requirement would have been huge and probably would have constituted dilution of the direct contact surface (in comparison to the indirect contact area) and they said they do accept the testing using representative sample , however needed 'test sample preparation including but not limited to material and manufacturing differences between the sample and finished device with rationale on why the test samples are representative of your finished device in terms of materials, manufacturing, sterilization, cleaning, etc and the justification for using weight/volume rather than surface area/volume')

 

 

Has anybody submitted such a declaration , is it possible for you to share the template with me ?

 

If the accessory is not manufactured by us , would the supplier then need to provide this declaration (to the FDA)?

 

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

.............................................................................
 
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Hello,

I agree with Ruthanne.  Biocompatibility is also contingent upon processing of materials during the manufacture of the device.  Please note if you are wishing to CE mark the device, biocompatibility must encompass the full finished device, have a look at Annex A.

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Gretchen Upton RAC
RA/QA
Texas
United States
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Original Message:
Sent: 11-May-2019 09:09
From: Rashmi Pillay
Subject: Biocompatibility declaration using representative sample

Hi,

 

Has anybody done a 510(k) submission using representative sample for testing instead of final device ?

 

I recently checked on the approach of representative sample testing with the FDA , described our device wherein the direct contact portion was very small and the final samples requirement would have been huge and probably would have constituted dilution of the direct contact surface (in comparison to the indirect contact area) and they said they do accept the testing using representative sample , however needed 'test sample preparation including but not limited to material and manufacturing differences between the sample and finished device with rationale on why the test samples are representative of your finished device in terms of materials, manufacturing, sterilization, cleaning, etc and the justification for using weight/volume rather than surface area/volume')

 

 

Has anybody submitted such a declaration , is it possible for you to share the template with me ?

 

If the accessory is not manufactured by us , would the supplier then need to provide this declaration (to the FDA)?

 

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.