Your question is a complex one. So, I will start with the standard "regulatory" response - it depends. I've seen situations where regulators insisted on following the standards as written and other situations where a justified approach worked. However, what I would recommend is approaching the sample size from a risk perspective. Hopefully, you've gotten your materials characterization done, and you've nailed your claims and indications for use down. Then, I would take all of the information you've got and formulate a plan based on the risk estimated from a toxicological assessment and the planned used, with safety factors built in.
Good luck!
Lisa
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Lisa Olson
Minneapolis MN
United States
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Original Message:
Sent: 30-Mar-2019 07:07
From: Rashmi Pillay
Subject: Biocompatibility sample requirement
Hi,
Where the patient contact area is very small as compared to the whole device, what is the area considered for biocompatibility testing , is it the whole surface area ? Because that wouldn't provide the correct representation of the actual contact area?. The test house, we were recently co-ordinating with , have requested for 1000 plus samples!
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
W ellex.com
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