FDA RELEASES DRAFT GUIDANCE ON MODIFICATIONS TO DEVICES SUBJECT TO PREMARKET APPROVAL

The FDA released draft guidance on the premarket approval (PMA) supplement decisionmaking process. The guidance is intended for manufacturers of Class III devices that are subject to PMA requirements.

It provides the criteria for industry and FDA staff to use in determining the type of PMA applications (original, panel track supplements, 180-day supplements, real-time supplements, Special PMA Supplements-Changes Being Effected, 30-day notices or periodic reports) that should be submitted to the FDA if a company modifies the design or labeling, the manufacturing process, the location of manufacturing, the processing or the packaging of a PMA device.

The guidance also gives examples of types of device modifications, along with descriptions of the testing performed to support each modification and types of PMA applications that were submitted for the modifications.

It does not address how to test specific devices to determine the effects of modifications.

The document, "Draft Guidance for Industry and FDA Staff -- Modifications to Devices Subject to Premarket Approval (PMA) -- The PMA Supplement Decision-Making Process," can be viewed at www.fda.gov/cdrh/ode/guidance/1584.html ( http://www.fda.gov/cdrh/ode/guidance/1584.html ).