This guidance, when finalized, will assist industry and Agency staff in determining when a software (including firmware) change to a 510(k)-cleared or a preamendments device subject to 510(k) (also referred to in this document as “an existing device”) may require a manufacturer to submit and obtain FDA clearance of a new premarket notification (510(k)).


For the current edition of the FDA-recognized standards referenced in this document, see the FDA Recognized Consensus Standards Database at

Posted on the FDA website on 8 August 2016