The U.S. Food and Drug Administration (FDA) said it has issued updated draft recommendations on new 510(k) filings for medical device modifications.
The recommendations are aimed at helping manufacturers determine when changes in existing medical devices are significant enough to warrant FDA review, including major changes to the intended use that could affect safety and effectiveness. Medical device technology evolves rapidly, and all changes made to marketed devices do not necessarily require a review by the agency, the FDA said.
Two guidances will eventually be finalized, one regarding minor changes that do not require FDA review, and another for major changes that do require review, the agency said. Together they will help ensure that the FDA receives appropriate submissions for modifications that require premarket review.
The draft guidance applies to medical devices subject to FDA premarket notification, for which manufacturers submit a "510(k)" document that shows that the device is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 when a manufacturer makes a major change in the intended use of the device, the FDA said.
The updated draft can be found on the FDA website here.
