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510k FDA review, will they accept Biocompatibility result generated using feasibility product lots?

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planB

Super Moderator
#2
If you can demonstrate, that your feasibility lot products are indeed representative for the final products as intended to be marketed, then you might be in a position to justify your approach. Have a look into ISO 10993-1:2018, sections 3.8 (definition of "final product") and 4.3 (relevant characteristics to consider in this evaluation).

Hope this helps,
 
#3
If you can demonstrate, that your feasibility lot products are indeed representative for the final products as intended to be marketed, then you might be in a position to justify your approach. Have a look into ISO 10993-1:2018, sections 3.8 (definition of "final product") and 4.3 (relevant characteristics to consider in this evaluation).

Hope this helps,
Thank you very much.
I have also heard that it is very hard to get FDA 510k approval if we use the feasibility lot for stability and biocompatibility. Is that true from anyone's experience? Thanks.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#5
FDA accepted our results as the product was made using real world production materials and equipment.

There was confusion from FDA about the use of our product on wet skin. We clarified this to state we claim our product is not to be used wet.

They also asked "The sensitization and irritation endpoints are intended to be tested through exaggerated extraction rather than clinical use. Exaggerated extraction of the device ensures that the worst case is accounted for and is more protective of patient safety when compared with testing for clinical simulated use. Without exaggerated extraction, we are unable to determine if the results are applicable to the subject device."

We refuted this claim about polar and non polar extraction as it is not consistent with Annex A of 10993.
 

pziemlewicz

Involved In Discussions
#7
Thank you very much.
I have also heard that it is very hard to get FDA 510k approval if we use the feasibility lot for stability and biocompatibility. Is that true from anyone's experience? Thanks.
It is all a question of risk. What is your 10993 classification and the difference between your feasibility lot and the production process?

Both sterilization and biocompatibility validations are expensive with long lead time; you will not want to do this twice. It might be worth discussing your plan during a Q-Sub. If you end up with a Refuse to Accept (RTA) letter during 510(k) review, there will likely not be enough time to complete these during the response window.
 
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