By U.S. Food and Drug Administration | August 5, 2016
The U.S. Food and Drug Administration today issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices.
“These draft recommendations are intended to help manufacturers determine when a change is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review.”
When finalized, the two guidances will provide improved clarity, regarding minor changes that do not require FDA review, and help ensure that the FDA receives appropriate submissions for modifications that do require premarket review by the agency.
The draft guidance documents apply to medical devices the FDA clears through premarket notification; manufacturers submit a “510(k)” document that demonstrates the device is substantially equivalent to another marketed device not subject to premarket approval (PMA). Federal law requires manufacturers to submit a new 510(k) when changes or modifications made to an existing device could significantly affect its safety or effectiveness or the manufacturer makes a major change or modification in the intended use of the device.