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 Timothy Ulatowski, the Director of the Office of Compliance for CDRH, has indicated that there will be an upcoming draft guidance for public comment (probably released in August) concerning his FDA division's usage of medical device companies' voluntary submissions of their ISO 13485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 Timothy Ulatowski, the Director of the Office of Compliance for CDRH, has indicated that there will be an upcoming draft guidance for public comment (probably released in August) concerning his FDA division's usage of medical device companies' voluntary submissions of their ISO 13485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