U.S. FDA Releases Draft Guidance on Demonstrating Substantial Equivalence

The U.S. Food and Drug Administration (FDA) has released a draft guidance that may help reduce the burden on device manufacturers seeking to demonstrate substantial equivalence for some types of new medical devices.

Published in April, the draft guidance “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria” describes an optional pathway for the recognition of certain types of medical devices under its Abbreviated 510(k) Program. Specifically, the guidance explains how the concept of “substantial equivalence” for certain types of devices may be demonstrated in a way that is less burdensome to the device manufacturer, but which still helps to ensure that requisite safety and performance requirements are being achieved.

Guidance documents are intended only to represent the agency’s current thinking on a given subject, and do not have the rule of law. However, they can be extremely helpful for device manufacturers seeking to successfully navigate the FDA’s device approval process.

Comments on the FDA’s draft guidance on the demonstration of substantial equivalence in medical device applications can be filed through July 11th at www.regulations.gov. (Cite docket number FDA-2018-D-1387). Read the complete text of the draft guidance.

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