Biocompatibility Testing - Multile products of different sizes and shapes

K

khann

Registered
#1
#1
We have several products with the same indication that are different sizes and shapes. If the contact material is the same in all of them (material, manufacturer and process) can we do the largest surface area product and cite that data in all of the PMA submissions?

Thanks,
Kathy
 
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William55401

William55401

Involved In Discussions
#2
#2
I think you are on the right track. I suggest reading (and applying) "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". It does include "worst case" language.

https://www.fda.gov/media/85865/download
 
M

monoj mon

Involved In Discussions
#3
#3
In addition to what William has said about the "Worst Case" from the context of "Largest Surface Area", I would like to mention about the "Worst Case" from the context of "Difficulty to Sterilize" (guessing your device as a sterile one) while doing the evaluation for the "Representative Device" to conduct the biocompatibility testing and document the decision making process.
 
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