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

Amendment Of 510(k) Exemption Petition Resets 180-Day Review Deadline

This article was originally published in The Gray Sheet

Executive Summary

Amendment of a 510(k) exemption petition will reset the 180-day review hammer set by the FDA Modernization Act, the agency says in its recently released "Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff."

You may also be interested in...



FDAMA 510(k) Exemption Provision Utilized By Abbott, Few Others

FDA approval of Abbott Laboratories' petition for 510(k) exemption for the firm's hypothyroidism total triiodothyronine (T3) test system would be the second for an Abbott T3 assay, albeit for a different indication.

EU’s SCCS Finds Endocrine-Disrupting Evidence Inconclusive In UV Filter Reassessments

While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.

UsernamePublicRestriction

Register

PS017586

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