FDA Updates Recommendations to Submit 510(k) for Device Modifications
(August 2016)

Under section 510(k) of the Food, Drug, and Cosmetic Act (FD&C Act), registered device manufacturers must report to the FDA 90 days before marketing new or modified medical devices. FDA is publishing a draft of updated recommendations for 510(k) medical device premarket safety notifications to help manufacturers determine when they should submit a new 510(k).

According to FDA, a Premarket Notification, otherwise known as PMN or 510(k), must be submitted before putting a product on the market to allow FDA to assess whether the device qualifies to be commercially distributed. A device meets these qualifications when it is as safe and effective as another legally marketed device not subject to premarket approval. Device manufacturers intending to introduce new devices or intending to modify a device that will significantly alter its safety and effectiveness must also submit a new form.

The first guidance was issued in 1997, but was retracted by FDA to make adjustments that comply with public input and federal legislation. These adjustments have been reworked to ensure more clarity in regards to when manufacturers must submit a new 510(k), including guiding principles, updated sections and flowcharts demonstrating when manufacturers will likely have to submit a new 510(k).