What does the FDA think about 13485? Will the FDA upgrade 21 CFR 820?

[Aaron Lupo]

I was wondering if anyone in the Medical Device Industry has heard any comments from the FDA on 13485:200x:

What does the FDA think about 13485?
Will the FDA upgrade 21 CFR 820? If yes how and when, if no, why?

I tried to do a search of the FDA site but was unable to loacte anything.

[Alf Gulford]

As I understand it, based mostly on an FDA teleconference a year or two ago, the FDA is planning on harmonizing, and maintaining harmonization, with ISO 13485.

I think this is based on the assumtion that ISO 13485 will remain more true to the medical device/regulatory viewpoint, which in turn is based on the GHTF having some ownership in the standard and the FDA is part of the GHTF. I could be playing fast & loose with some of the facts here but this seems to be the bottom line.

On the other hand, I just finished going through a 2 day workshop on ISO/CD 13485 (now I have to update my notes to apply to the DIS version) and I don't know how far the FDA wants to go down this 'process management' path. They're still basically a law enforcement agency, not management consultants (aren't they?).

By the way, the workshop facilitator was placing some importance on SA 8000 ( the 2001 revision is available free(!) at www.cepaa.org ), saying that he expects domestic companies to have to start addressing it within about 4 years. I agree, but I think that will be for companies that want to sell internationally. Eventually I think, as I've droned on about before, that ISO 14001 and SA 8000 will be a requirement for doing business in Europe.

Alf

[Aaron Lupo]

Alf I dont mean to sound dumb but what is GHTF?
As far as the work shop you attended do you have any information you might be able to pass my way?

[Alf Gulford]

Morning, ISO GUY-

Nothing dumb about it. I should have mentioned that I was talking about the Global Harmonization Task Force. If you're not familiar with them you should bookmark their site (www.ghtf.org ) and keep an eye on them. I don't remember all the details (see their General Information page) but the FDA is part of the effort to harmonize regulations around the world. BTW - You might find their document #SG3.N99-10, Process Validation Guidance really interesting.

As far as the workshop goes, as I get time I'm going through my notes to see what I really need to focus on. Most of it, as you know, is the same as ISO 9001:2000 and the instructor really focused on the increased importance of the Management Review and the Analysis of Data. We collect tons of data but I don't think we use it very effectively.

If I see anything really earth-shaking I'll be sure to post it.

Alf