FDA Provides Draft Guidance for 510(k) Premarket Submission

The U.S. Food and Drug Administration (FDA) has issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission. Although this process is the most common review path for lower-risk devices, it has been a source of controversy for many manufacturing firms due to its somewhat vague guidelines.

In keeping with tradition, changes that significantly could affect a product’s safety, effectiveness or intended use require an additional 510(k) submission. But the draft guidance names the specifics manufacturers have been asking for. According to the draft, changes that require action include specific types of labeling revisions, changes to technology, changes in performance specifications, manufacturing alterations, and changes in the materials used to make the device.

“We are making the regulatory process for medical devices less challenging by better describing our expectations,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “In particular, manufacturers can continue to make innovative improvements to their devices and better plan for any updated submissions. This saves time and money.”

The draft guidance is one of 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations launched in 2011 to enhance predictability, consistency and transparency of the agency’s premarket review programs. When final, it will supersede the Deciding When to Submit a 510(k) for a Change to an Existing Device guidance document from 1997.

For more information:

510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change in an Existing Device, Draft Guidance
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo…

FDA: Medical Devices
http://www.fda.gov/MedicalDevices/default.htm

CDRH Plan of Action for 510(k) and Science
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm