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FDA Releases New De Novo Review Guidance

NEW YORK (GenomeWeb News) – The US Food and Drug Administration today published a guidance document aimed at helping makers of certain medical devices prepare to submit their diagnostic and therapeutic products for pre-market approval applications and de novo petitions.

The new document was created to provide guidance and nonbinding recommendations for device manufacturers and reviewers on how the PMA and de novo process works for devices that are of low or moderate risk or different from existing devices and Class III devices.

"This guidance clarifies this process for industry, which will provide manufacturers with greater predictability, consistency, and transparency in FDA decision-making while allowing manufacturers and the FDA to use a common framework for benefit-risk determinations," Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said in a statement.

It outlines the systematic approach device reviewers take when conducting risk determinations, and provides the device reviewers a guide for the review process.

These determinations address the type, magnitude, and duration of a risk or a benefit, the probability that a patient will experience the risk, and the availability of alternative treatments.

The guidance also provides device makers with a tool to explain the various factors FDA reviewers will consider during the pathway for high-risk devices, de novo petitions, and low-to-moderate risk devices.

"In addition to bringing clarity to our decision making for industry, this guidance will provide our reviewers with uniform and consistent guidelines to assess probable benefits and risks," Shuren added.

FDA said that CDRH plans to train medical officers and device reviewers on the guidance and how to apply it consistently, and it currently is developing training modules to help industry and device sponsors understand how it plans to apply the new guidance. The agency will begin applying it to incoming de novo and PMA submissions at the beginning of May.

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