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

FDA Hints At Possible 510(k) Tweaks At Public Meeting

This article was originally published in The Gray Sheet

Executive Summary

FDA is considering changing how predicate devices are selected for 510(k) submissions and beefing up its post-market authorities for 510(k)-cleared products, agency reps suggested at a Feb. 18 public meeting

You may also be interested in...



FDA Faces Challenges In Writing Reg For 510(k) Transfers Of Ownership

FDA’s device center thought a planned proposed regulation for requiring 510(k) transfer-of-ownership updates would be a “pretty simple idea,” but it turned out to be more complicated than expected.

CDRH Pre-Market Reform Proposals Expected Within Weeks

The FDA device center's upcoming proposals for reforming its pre-market policies will directly address widespread industry concern that reviews are increasingly unpredictable and opaque, CDRH Director Jeff Shuren told an industry audience last week

CDRH Pre-Market Reform Proposals Expected Within Weeks

The FDA device center's upcoming proposals for reforming its pre-market policies will directly address widespread industry concern that reviews are increasingly unpredictable and opaque, CDRH Director Jeff Shuren told an industry audience last week

Related Content

Topics

UsernamePublicRestriction

Register

MT028525

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