Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


Industry To FDA: 1 Year Isn’t Enough Time To Transition To New QMSR Rule

Executive Summary

Stakeholders and industry groups at a 2 March US FDA panel meeting said two years, not one, will be needed for device makers to comply with the agency’s proposed Quality Management System Regulation, which when finalized will replace the current Quality System Regulation.

You may also be interested in...

Philips, Hamilton Medical To FDA: QMSR Shouldn’t Subject Devices To ISO Traceability Requirements

The makers of breathing machines said in comments to the US agency that it must address language in its draft Quality Management System Regulation that the companies say would place onerous traceability requirements on most medical devices.

‘If You Know The Answer, Let Me Know’: FDA’s Shuren Mum On 1 Year Transition For Coming QMSR Reg

Jeff Shuren, director of the US FDA’s device center, said on 4 May that the agency “thought it was enough time” when it proposed a one-year transition time frame from its current Quality System Regulation to the new Quality Management System Regulation.

QMSR Quick Take: Medtech Consultant Steve Silverman

Steve Silverman, a former compliance director for the US FDA’s device center, gives a quick take on the agency’s proposed Quality Management System Regulation. The QMSR would replace the FDA’s current Quality System Regulation.

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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