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

UsernamePublicRestriction
UsernamePublicRestriction

Are You On The List? FDA ID’s Devices That Might See Less Premarket Data Or Downclassification

This article was originally published in The Gray Sheet

Executive Summary

CDRH says it exceeded its goal to retrospectively review half of all pre-2010 PMA device types. So far, 21 categories have been slated as candidates for downclassification and another 21 may be tagged for shifting some data requirements to the postmarket.

You may also be interested in...



Top 15 In '15: The Most-Read "Gray Sheet" Stories Of The Year

The most popular "Gray Sheet" stories in 2015 dug deep into regulatory developments and concepts, and provided guidance on how to respond. Quality control topics and analysis of FDA's premarket review processes dominates the list.

FDA Guidance Allows Limited Foreign Data To Approve Devices With Postmarket Caveat

As FDA puts more emphasis on postmarket data collection in its PMA approval process, the agency has released a final guidance on balancing premarket and postmarket studies.

Leap Ahead With EAP? FDA Proposes New Expedited PMA Pathway

The newly proposed “expedited access” PMA program combines early and outsized interactions between reviewers and manufacturers with the promise of lightened premarket requirements for selected products – if the potential payoff to patients is large enough and postmarket controls are sufficient.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

MT033848

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

Cancel