Should 510(k) Predicates be Actively Listed Devices?

Watchcat

Trusted Information Resource
How does that work? Suppose you have 10000 active FDA 510(k) approved devices operating in the USA. If the 510(k) is pulled how are AE reported?

This is probably just a theoretical discussion, because I'm doubtful 510(k)s get pulled. However, if there were a serious enough problem to pull the device from the market...and the 510(k) from the database, I would think the 10,000 devices would have been recalled, no?

Otherwise, not clear why you need a 510(k) to report AEs.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
This is probably just a theoretical discussion, because I'm doubtful 510(k)s get pulled. However, if there were a serious enough problem to pull the device from the market...and the 510(k) from the database, I would think the 10,000 devices would have been recalled, no?

Otherwise, not clear why you need a 510(k) to report AEs.
Well lets make it more generic. What is a company goes bankrupt and there is reason to initiate a recall? Is there some insurance there?
 

Watchcat

Trusted Information Resource
Do you mean if it left devices in use, is there some way to still get them recalled after the bankruptcy? Or is there some way to assure that no one tries to use their device as a predicate?

On the recall, so many different scenarios, hard to say. If it is used in a hospital setting FDA could probably send out a Dear Doctor letter. If it is an OTC product, then FDA would probably issue a press release for the media to pick up and alert consumers, like other consumer advisories, more commonly about tainted food products.

As for pulling the 510(k), I still don't know, but I have remembered that recall listings are part of the total lifecycle reports:

TPLC - Total Product Life Cycle

So as long as you do your due diligence on your predicates, you're good, whether the 510(k) itself has been pulled or not.
 
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