Upcoming FDA ISO 13485 audit guidance (draft version)

[Dustyn Webb]

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 Timothy Ulatowski, the Director of the Office of Compliance for CDRH, has indicated that there will be an upcoming draft guidance for public comment (probably released in August) concerning his FDA division's usage of medical device companies' voluntary submissions of their ISO 13485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

[Wes Bucey]

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.

[MIREGMGR]

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]

Originally Posted by MIREGMGR

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!

[Dustyn Webb]

Originally Posted by MIREGMGR

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]

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.

[Gert Sorensen]

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

[chris1price]

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