FDA issues draft guidance on when to seek reapproval for medical devices

Editor's Note

The Food and Drug Administration (FDA) on August 8 published draft guidance on when medical device manufacturers and software developers must obtain FDA clearance before making changes to existing products, the August 8 Modern Healthcare reports.

The draft says if the “overall structure” of a device’s software is altered, the manufacturer should consider filing a 510(k) that demonstrates the device is safe and effective. An example would be software tweaks to support new hardware.

Comments on the draft guidance will be accepted for 90 days.

The Food and Drug Administration issued draft guidance Monday that clarifies when medical device manufacturers and software developers must receive regulatory approval before making changes to their products. The proposal states alterations to the "overall structure" of a device's software should be considered for a new FDA 510(k) that demonstrates a marketed medical device is safe and effective.