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Dec 23, 2024 · This database provides the most up-to-date list of voluntary consensus standards to which FDA will accept a Declaration of Conformity for medical devices.

Oct 1, 2024 · Effective and meaningful participation in standards development organizations (SDOs) for the products FDA regulates are critically important. The use of standards can increase predictability,...

Sep 20, 2024 · Standards that have been recognized by the FDA (either wholly or in part) are maintained and are searchable in the FDA's Recognized Consensus Standards Database.

Jan 4, 2023 · This latest update, known as “List 59,” includes new standards and new versions of recognized standards, as well as revisions to some standards’ extent of recognition and extended the transition period for two standards.

Jan 14, 2025 · The U.S. Food and Drug Administration (FDA) recently updated its Recognized Consensus Standards database. This latest update, known as “List 63,” includes the following changes and others:

Jul 3, 2024 · Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at...

Safety requirements for secondary batteries and battery installations - Part 1: General safety information.

Dec 23, 2024 · To search by Standards Organization, Type of Standard, Product Area, Product Code, Regulation Number, Reference Number or Title, select Go to Advanced Search button. Page Last Updated:...

Jul 26, 2023 · This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center can use to make an appropriate decision regarding the clearance or approval of a submission.

Dec 23, 2024 · The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892. For more information on FDA Product Codes, please visit...