ARTICLE
23 October 2018

FDA Rolls Out Pilot Of New Quality In 510(k) "Quik" Review Program

DM
Duane Morris LLP

Contributor

Duane Morris LLP, a law firm with more than 800 attorneys in offices across the United States and internationally, is asked by a broad array of clients to provide innovative solutions to today's legal and business challenges.
On September 6, 2018, the FDA launched an alternate to the Traditional 510(k) for submitting a Premarket Notification (510(k)).
United States Food, Drugs, Healthcare, Life Sciences

The 510(k) process provides a review procedure for marketing clearance of devices that are "substantially equivalent" to other approved devices or to a standard recognized by the Food and Drug Administration (FDA).

On September 6, 2018, the FDA launched an alternate to the Traditional 510(k) for submitting a Premarket Notification (510(k)). The FDA calls the alternative the Quality in 510(k) "Quik" Review Program Pilot. Under the program, the FDA's goal is "to make a final decision within 60 days."

Read the full text of this Alert on the Duane Morris LLP website.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.

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