FDA issues new draft recommendations for medical device manufacturers

The FDA has published draft updated recommendations that assist manufacturers with knowing when they are legally required to notify the FDA about medical device modifications. An additional guidance focused on software devices was also published.

The two documents, once finalized, will replace a guidance that dates back to 1997.

“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,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a prepared statement. “Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review.”

These documents apply to devices that require premarket FDA clearance. Manufacturers are required to submit a new 510(k) document “when changes or modifications made to an existing device could significantly affect its safety or effectiveness” or when “the manufacturer makes a major change or modification in the intended use of the device,” per the FDA’s statement.

Manufacturers will notice that the updated recommendations include updated information on when details such as product labeling, building materials, and performance changes warrant a new 510(k) form to be submitted. Specific examples of when a new form is and is not needed are also included.

The draft updated recommendations can be read in full on the FDA’s website. The software-specific guidance is available as well.

Public comments, questions and suggestions can be submitted to the FDA for up to 90 days after the documents’ release.