domingo, 15 de abril de 2018

FDA seeks comments on Expansion of the Abbreviated 510(k) Program

The FDA is seeking comments on the draft guidance Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria by July 11th, 2018.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.

We welcome your comments regarding this draft guidance. The comment period will be open for 90 days in the Federal Register under docket number FDA-2018-D-1387 starting April 12, 2018.

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or

Food and Drug Administration
Center for Devices and Radiological Health

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