ARTICLE
13 April 2016

FDA Announces Modifications To FDA Recognized Consensus Standards For Premarket Reviews Of Medical Devices

JD
Jones Day

Contributor

Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
In the April 4, 2016, Federal Register, FDA announced a publication containing modifications the Agency is making to the list of standards it recognizes for use in premarket reviews.
United States Food, Drugs, Healthcare, Life Sciences

In the April 4, 2016, Federal Register, FDA announced a publication containing modifications the Agency is making to the list of standards it recognizes for use in premarket reviews ("FDA Recognized Consensus Standards"). This publication, titled "Modifications to the List of Recognized Standards, Recognition List Number: 041," will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. The modifications were effective April 4, 2016.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More