FDA Updates Database of Recognized Consensus Standards for Medical Devices

The U.S. Food and Drug Administration (FDA) has updated its list of recognized standards that can be used in support of premarket submissions for medical devices.

Notification regarding the changes to the FDA’s searchable database of recognized consensus standards was published on the FDA website in late December. However, details on the specific standards added to, withdrawn from or replaced on the list of recognized standards are available in a Notice published in the Federal Register in late October.

The changes include the addition of nearly 40 standards to the list, as well as the withdrawal and replacement with new versions of more than 40 additional standards.

Demonstrating conformity with FDA-recognized standards helps facilitate the premarket review process for Premarketing Notifications (510(k)s), Premarket Approval (PMA) and other approvals for medical devices and drugs by the Agency.

Read the FDA’s Notice regarding modifications to its of recognized consensus standards as published in the Federal Register.

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