Revisions include new and revised recognized standards

If your email program has trouble displaying this email, view as a webpage. FDA Updates Recognized Consensus Standards Database The U.S. Food and Drug Administration (FDA) updated its Recognized Consensus Standards database to include new and revised recognized standards, as well as revisions to some standards' extent of recognition or transition periods. View the Database According to the FDA's guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, the FDA may determine which new or revised standards are appropriate for meeting requirements for medical devices under the Federal Food, Drug, and Cosmetic Act, and may issue recognition numbers and provide supplemental information in the Recognized Consensus Standards database  in advance of a Federal Register Notice. These standards may be used to support declarations of conformity in submissions. The next Federal Register Notice with modifications to the list of recognized consensus standards for List 55 will be published in 2021, though manufacturers may now cite these new and revised standards in device submissions. Nine standards included in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot have new versions in the updated Recognized Consensus Standards Database. Check the database and the relevant Supplementary Information Sheets for more information. Questions? If you have questions, contact the Division of Industry and Consumer Education.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA