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Upcoming FDA ISO 13485 audit guidance (draft version)

D

Dustyn Webb

#1
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 Timothy Ulatowski, the Director of the Office of Compliance for CDRH, has indicated that there will be an upcoming draft guidance for public comment (probably released in August) concerning his FDA division's usage of medical device companies' voluntary submissions of their ISO 13485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.
 
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Wes Bucey

Quite Involved in Discussions
#2
Re: upcoming FDA ISO audit guidance

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.
 
M

MIREGMGR

#3
Re: upcoming FDA ISO audit guidance

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.
 

howste

Thaumaturge
Super Moderator
#4
Re: upcoming FDA ISO audit guidance

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!
 
D

Dustyn Webb

#5
Re: upcoming FDA ISO audit guidance

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.
 

Ajit Basrur

Staff member
Admin
#6
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.
 
G

Gert Sorensen

#7
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:
 
D

Dustyn Webb

#9
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).
 
A

Aaron Lupo

#10
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.
 
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