FDA Issued the Draft Guidance on the Expansion of the Abbreviated 510(k) Program

Today, the United States Food and Drug Administration (FDA) has issued the Draft Guidance on the Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. The FDA is seeking comments by July 11th, 2018.

This guidance expands the potential use of the Abbreviated 510(k) Program, allowing for less burdensome demonstrations of substantial equivalence for certain device types while maintaining the statutory standard for demonstrating substantial equivalence. The guidance describes an optional pathway for certain, well-understood device types, where a submitter would demonstrate that a new device meets FDA-identified performance criteria to demonstrate the device is as safe and effective as a legally marketed device (predicate device).

The FDA believes that least burdensome principles should be widely applied to all activities in the premarket and postmarket settings to remove or reduce unnecessary burdens so that patients can have earlier and continued access to high quality, safe, and effective devices. The FDA defines least burdensome to be the minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time. The principles are based on sound science, the intent of the law, the use of alternative approaches, and the efficient use of resources to effectively address regulatory issues.

The Expansion of the Abbreviated 510(k) Program aligns with these principles, potentially allowing for increased efficiency and flexibility in submission and review of beneficial new devices, while meeting the statutory requirements for clearance.

Download the FDA Draft Guidance below or here >>

Download “Expansion of the Abbreviated 510K Program” UCM604195.pdf – Downloaded 1164 times – 418 KB

Date: 2018-04-11

FDA Guidance on Expansion of the Abbreviated 510k Program
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