FDA Approved Class II Medical Device?

[DonkeyKang]

I can't seem to find a straight answer on this. My company likes to refer to things as "FDA Approved", but since we are developing a class II medical device, we are not FDA "Approved", but rather "Cleared" via 510(k). My question is - can a Class II medical device ever claim to be "FDA Approved", since a Class II device doesn't require a PMA?

 

[Jaydub]

I am not an expert, but I know my last employer was chided by an FDA inspector for saying on our website that a 510(k) cleared device was "FDA Approved". The website was updated while the FDA inspector was still there and nothing was written up.

 

[Ronen E]

I can't seem to find a straight answer on this. My company likes to refer to things as "FDA Approved", but since we are developing a class II medical device, we are not FDA "Approved", but rather "Cleared" via 510(k). My question is - can a Class II medical device ever claim to be "FDA Approved", since a Class II device doesn't require a PMA?

No.

 

[Watchcat]

Yes, you can, but should you?

CDRH will say no if you ask it, but it's pretty commonly done (especially in press releases) and CDRH rarely goes out of its way to address it. Jaydub's experience is pretty typical. Picked up on an inspection, not because CDRH on the lookout, and then just "chided" and let go once it was changed.

It might get more attention if your competitors complain to CDRH about it.

If you have another issue that makes CDRH unhappy, it's unhappiness is likely to escalate if it finds you are also touting a cleared device as approved, And once you have its attention, it will probably notice.

Depending on how knowledgeable your customers are, it could also do your credibility some damage. I know I'm not impressed when I see a company do this. I tend to attribute it to ignorance, rather than to malice, but I'm not impressed by ignorant companies. In particular, I have found many physicians are keenly aware of the difference, so I wouldn't recommend making this mistake with them.

 

[DonkeyKang]

Thanks for the responses guys. So, in a nutshell, there is no such thing as an "FDA Approved Class II Medical Device".

This seems like a pretty big deal that isn't really mentioned a whole lot.

 

[Watchcat]

This seems like a pretty big deal that isn't really mentioned a whole lot.

Ah, well, in the whole great scheme of things, I probably wouldn't go so far as "pretty big deal," but I'm old and have seen a lot of deals, lol. I think it's enough of a deal that management should at least be made aware of 21 CFR Part 807.97:

CFR - Code of Federal Regulations Title 21

 

[Ronen E]

This seems like a pretty big deal that isn't really mentioned a whole lot.

I think that it's pretty well known across the industry, that's why it's not discussed intensively. It comes up in Elsmar every once in a while.
How intensively it's being enforced, I do not know. I remember reading several warning letters issued for this cause.

 

[DonkeyKang]

Is there any situation where validating against the predicate "because it's FDA Approved" is logical?

 

[Watchcat]

If the predicate was the subject of a PMA that was submitted to and approved by FDA, then at least the notion of an "FDA Approved" predicate is logical. As for the rest, I'm not sure what you mean by "validating against the predicate."

 

[DonkeyKang]

I'm not sure what you mean by "validating against the predicate."

Using the predicate device (Class II, subject of a 510K) a the "gold standard" for accuracy validation of new device.