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

UsernamePublicRestriction

FDA Seeks Comments On Proposed Rule For Releasing Cleared 510(k)s

This article was originally published in The Gray Sheet

Executive Summary

Copyrighted material that has not been redacted by 510(k) applicants would be released on the Internet under FDA's proposed rule for redaction of cleared 510(k)s. Comments are due by March 20.

You may also be interested in...



FDA 510(k) Redaction Proposal For All 510(k)s Lacks Justification - Industry

FDA's proposal that all 510(k) sponsors must provide redacted versions of their submission upon clearance is unnecessary given the small number of Freedom of Information Act requests, the National Electrical Manufacturers Association asserts in March 20 comments to the agency.

FDA 510(k) Redaction Proposal For All 510(k)s Lacks Justification - Industry

FDA's proposal that all 510(k) sponsors must provide redacted versions of their submission upon clearance is unnecessary given the small number of Freedom of Information Act requests, the National Electrical Manufacturers Association asserts in March 20 comments to the agency.

FDA's Redacted 510(k) Proposed Rule Exceeds Statutory Authority - MDMA

FDA's proposed rule requiring 510(k) applicants to commit to providing redacted versions of 510(k)s within 30 days of FDA clearance exceeds the agency's statutory authority, according to comments submitted March 21 by the Medical Devices Manufacturers Association.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT012764

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

Cancel