US FDA Issues Draft Updated Recommendations on Submitting a New 510(k) for Device Modifications

The U.S. Food and Drug Administration (FDA) 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.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that the FDA receives appropriate submissions for modifications that do require premarket review by the agency.The draft guidance documents apply to medical devices the FDA clears through premarket notification; manufacturers submit a “510(k)” document that demonstrates the device is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.The draft recommendations describe how manufacturers should consider the risk presented by the device modifications when determining if they should submit a new 510(k). When finalized, they will replace an earlier guidance issued in 1997.Read more at DermWire.