PMA Supplement Required?

[BostonAngler]

Its pretty clear that a 30 day supplement is required for a new supplier of a critical material. I'm curious if anyone working with Class III medical devices has ever reactivated an old supplier of a critical raw material. Does that require a 30 day supplement too? (no changes to specification or the vendor's material. )

 

[planB]

In case you adequately maintained your supplier and did not terminate your supplier relationship, I see no trigger for a supplement.

Hope this helps,

 

[BostonAngler]

marc, thanks for your input. no, we didn't keep up with supplier maintenance i.e. audit/survey etc. so guessing that changes your opinion?
thanks

 

[planB]

This still might be OK, as long as no delivered article is affected by this phase of suspended supplier control. You may want to make sure that you re-install all your defined elements of supplier control again, before you place the first order of material used for production.

Hope this helps,