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Expert: Granting More Than 1 Year To Comply With QMSR Rule Puts FDA In A Pickle

US Regulatory Roundup, May 2022

 
• By Shawn M. Schmitt

Many commenters on the US FDA’s draft Quality Management System Regulation want two or three years to comply, but one medtech expert says that length of time could put the agency in a difficult position. Our coverage of the FDA’s draft QMSR – and an array of other news and analysis – topped our list of most-read Medtech Insight stories in May.

US Top Stories
• Source: Alamy

How much time does the medtech industry need to comply with a final version of the US Food and Drug Administration’s Quality Management System Regulation? Well, if you read many of the 69 comments to date from stakeholders on the draft QMSR, you’d think the answer is two to three years.

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More from Policy & Regulation

Secretary Kennedy’s FDA Visit Included CDRH Stop, Speech Warning Of ‘Agency Capture’

 
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