Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Good Deal? Firms Seek Details On FDA ISO Audit Report Submission Program

This article was originally published in The Gray Sheet

Executive Summary

Device makers generally support FDA's plan for accepting voluntary international audit reports as a means for possibly delaying an FDA inspection, but firms say more details need to be spelled out before many will agree to participate

You may also be interested in...

CDRH Prepares For Electronic Recall Submissions; Pre-Market Still A Challenge

Device recall reports may be submitted via FDA’s eSubmitter platform beginning in the coming months. Meanwhile, full-fledged electronic submissions of pre-market device applications are still a ways off.

Draft Guidance: Clean ISO Audit Report May Permit Delayed FDA Inspections

Device companies may be able to put off an FDA facility inspection if the plant has recently satisfied international quality system standards, according to a 1draft guidance released by the agency May 20

FDA Will Inspect Firms That Didn’t Participate In U.S.-Canada Program

Manufacturers that turned down FDA's offer to participate in its Pilot Multipurpose Audit Program (PMAP) will soon be inspected by the agency, CDRH's compliance chief says

Related Content





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts