FDA Issues Guidance on Low- to Moderate-Risk Devices

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The U.S. Food and Drug Administration (FDA) has announced that it has issued for manufacturers a draft guidance that updates and streamlines the evaluation of automatic class III designation, the de novo review process used for certain innovative, low- to moderate-risk medical devices that do not meet the requirements for clearance under the 510(k) review process.

Devices are currently considered for the de novo program only after only after the agency has rejected a 510(k), establishing that the device is not substantially equivalent to another legally marketed device. However, the draft guidance specifies a pathway for a concurrent 510(k) and de novo petition without duplicative data requirements. This streamlines the process by up to 90 days and fosters more efficient, early interaction between manufacturers and the FDA, according to the agency.

The draft guidance also provides clarifies for manufacturers the issue of the suitability of a device for the de novo process.

"Right now, the de novo process is cumbersome and requires extra work and effort from manufacturers and the agency," states Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health. "Creating a pathway for a concurrent 510(k) and de novo petition streamlines the de novo program, helping speed safe and effective devices to patients."

The draft guidance is one of 25 action items listed in the FDA's Plan of Action for Implementation of 510(k) and Science Recommendations launched earlier this year to improve the predictability, consistency, and transparency of its premarket review programs.

The FDA is seeking comments about the draft guidance. To view the document and for instructions on how to submit comments, click here:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo...