Some very good news for American ISO 13485-certified medical device manufacturers...

Mr. Timothy Ulatowski, the Director of the Office of Compliance for CDRH, has indicated that there will be an upcoming draft guidance for public comment (probably released in August) concerning his FDA division's usage of medical device companies' voluntary submissions of their ISO 13485 audits, allowing his division to deschedule those companies who have submitted satisfactory QMS audits by their Notified Bodies, and focus CDRH resources on auditing non-ISO certified medical device companies. In a phone conversation, Mr. Ulatowski indicated that a final guidance could possibly be released by the end of this year, also stating that CDRH resource management was a key driver of this initiative.

See the attached FDANEWS (July 11, 2008) release concerning this development.

That will definitely be good news for medical device manufacturers who have spent the time and effort to become registered to ISO 13485.

In point of fact, many different governments have similar policies for their regulators vis a vis registration to ISO 13485. Some governments even make registration to ISO 13485 a prerequisite for medical device manufacturers to sell their products in that country. Further, some of those governments even have lists of "acceptable registrars."

Thanks for bringing this to our attention.

Actually he said this on July 11, I think...and supposedly the new Guidance was going to be released that month, i.e. it's late.

I've been checking fda.gov daily for the past two weeks.

Actually he said this on July 11, I think...and supposedly the new Guidance was going to be released that month, i.e. it's late.

I've been checking fda.gov daily for the past two weeks.

Be sure to let us know when it's available. Thanks!

Actually he said this on July 11, I think...and supposedly the new Guidance was going to be released that month, i.e. it's late.

I've been checking fda.gov daily for the past two weeks.
Thanks for the date correction. I transposed the second 1 in eleven to the 7 in seventeen. Might be a sign of dyslexia or Alzeimers. I also have been searching the FDA website for 2-3 weeks, and finally gave up to call the Office of Compliance Director to get an idea of when they were going to release the draft of this new CDRH direction. Thought of posting here and alerting others to an upcoming positive development today.

Thanks for the information, MIREMGR and Dusyn. Pl comeback when you have more information as it will be very useful to all, in US and elsewhere too.

It is going to be very interesting to see if this will also apply to those of us located outside of the U.S. :confused:

This could be very interesting, please keep us all informed of its progress.
chris

My guess (and only a guess) is that it will apply to foreign medical device manufacturers, if their current satisfactory audits have been done by a notified body recognized by the FDA. We should know more soon, when the draft for public comment is released in the next month (quote from the Director of the CDRH Office of Compliance).

Correct me if I am wrong but hasn’t he FDA had a program in place called the Accredited Persons for quite some time now, I think it has been in place for over five years now. If you go to the FDA website, you will be able to find information on this. The information you posted is from the FDANEWS.Com site, which is not the same as FDA.GOV.

Correct me if I am wrong but hasn’t he FDA had a program in place called the Accredited Persons for quite some time now, I think it has been in place for over five years now. If you go to the FDA website, you will be able to find information on this. The information you posted is from the FDANEWS.Com site, which is not the same as FDA.GOV.
With the accredited person program you can opt to have an audit done to the FDA Requirements by an individual who has been vetted by FDA. The FDA QSR is more prescriptive than ISO13485 so it will be interesting to see their rationale to accept audits to ISO13485 requirements.

Yes, I am familiar with the accredited person program that you mention, but I think that this new iniative is different. It appears to potentially be a change of FDA/CDRH philosophy, if the blurb in FDANEWS and my phone conversation with the Director of the CDRH Office of Compliance (Timothy Ulatowski) truly give the flavor of the upcoming ISO audit guidance draft. Of course, the draft will invite public comment, and will potentially change before becoming the final guidance. Maybe we are seeing the FDA moving closer to global harmonization in this area, and effectively saving resources at the same time.

Correct me if I am wrong but hasn’t he FDA had a program in place called the Accredited Persons for quite some time now (...)

The Accredited Persons Inspection Program (APIP) has a different purpose.

From the FDA document "Accredited Persons Inspection Program", "the intent of these provisions is to focus the use of third party inspections on manufacturers that operate in a global market and are likely to be subject to multiple inspection requirements." That is, a qualifying device maker can arrange to have its inspector for a different nation's rules and standards also audit/inspect for FDA rules and standards at the same time...but the inspections are separate from each other, and are just done by the same person at the same time. The APIP is specifically required to prepare and file an FDA-equivalent inspection report.

There are some limitations:

Per "Inspection of Medical Device Manufacturers", APIP inspections can only be Level 2. A routine surveillance inspection by FDA of a Class II device maker, other than their first-ever inspection, is Level 1, and covers CAPA plus either Production and Process Controls (P&PC) or Design Controls. Level 2 inspections are required to cover CAPA, P&PC, Design Controls and Management Controls.
Only firms with a prior FDA inspection finding of No Action Indicated or Voluntary Action Indicated are eligible for participation in APIP.
The firm must market devices both in the US and in one or more other countries.
The FDA has to pre-approve a firm's intent to use an APIP, and then pre-approve the firm's specific choice of APIP based on the non-US contry where marketing is intended and the medical device type or types to be inspected.
A firm that has any significant adverse finding in an APIP inspection and receives an Official Action Indicated determination, that firm is ineligible for further participation in APIP without jumping through some FDA re-qualification hoops.
A firm can have no more than two consecutive APIP inspections, following which it must be inspected by FDA.
My understanding of the upcoming program is that ISO surveillance audits will be routinely accepted, and the program will apply to all companies that make Class II devices and thus are subject to regular FDA surveillance; are ISO registered; and have a relatively clean record, i.e. aren't subject to a For Cause or Follow-up inspection.

If that's a correct understanding of the upcoming requirements, the new program will be much more comprehensively applicable.

Some one leting us know when the draft guidance would be published would be the best.

I hadn't seen any further information publically announced or posted yet as of last Friday, and I try to check every day.

Earlier in the thread there was some discussion of the existing APIP program, which has a trial status. Three months ago the FDA had announced a comments collection period for that program, but they didn't receive any. This morning they published in the Federal Register an extension of the comments period.

FYI, the FDA estimates that the APIP program may be used by about 100 device manufacturers per year, due to the many restrictions on participation.

None of this has anything to do with the Timothy-Ulatowski-discussed program for acceptance of ISO audits in place of FDA audits, for which there still hasn't been any further public disclosure.

Is there an update to this thread? I have an email today with the following guidance, "Requests for Inspection Under the Inspection by Accredited Persons Program--21 U.S.C. 374(g) (OMB Control Number 0910-0569) - Extension. It is from Federal Register/Vol. 73, No. 169/Friday, August 29, 2008.

This guidance is to apply for a third party inspection in lieu of an FDA inspection. I was under the impression from the earlier post that you would be able to submit your existing third party inspection to preclude the FDA inspection.

Is this the guidance that we have been waiting for? It will not be applicable to my company anyway because we do not market in the US.

I really appreciate all the information I have gotten from this forum.

I posted in response to your question, while you were preparing your post. How's that for a prompt answer? :D

SGS is part of the AP programme. However no-one will deny that the programme has been pretty unsuccessful - 100 manufacturers across all registrars is a very small number.

There are a number of reasons why the scheme hasn't really taken off, as confirmed by FDA to the GAO. Something along these lines:

1) Companies tend to not want FDA to come in at all.
2) They certainly don't want to have to pay for the privilege.
3) The qualification process for registrars and their individual auditors has been costly and logistically difficult.

The main 'market' is foreign companies that need FDA to inspect their facilities, but are located in places that FDA isn't getting to. (Which immediately after 9/11 was pretty much everywhere, situation is somewhat better now).


So whilst the proposal to 'accept' ISO13485 certification isn't connected to the AP programme, it is indirectly related. Had the AP programme been wildly successful, this current proposed policy probably wouldn't have been necessary.

A bigger driver is clearly the fact that the average time between FDA inspections of foreign manufacturers isn't the two years it is supposed to be, rather the twenty-seven years it currently is. FDA is taking a very sensible step in my opinion, taking risk-based decisions to put its limited resources where it needs to. :applause:

According to The GMP Letter (http://www.fdanewspubs.com/ls.cfm?r=161187717&sid=4987786&m=582645&u=FDANews_Ma&s=http://www.fdanews.com/newsletter/subscribe/options?newsletterId=17), a commercial newsletter pertaining to FDA matters, the FDA’s planned guidance for devicemakers to voluntarily submit International Organization for Standards (ISO) audit reports has been delayed. CDRH’s Kim Trautman says that the FDA hopes to release it by the end of this year.

Under the ISO plan, manufacturers will be able to submit ISO 13485 reports from audits conducted by notified bodies to satisfy European, Canadian and Australian regulatory requirements.