FDA RELEASES DRAFT GUIDANCE ON DEVICE MODIFICATIONS

New draft guidance advises manufacturers of Class III devices subject to premarket approval (PMA) requirements on when to use certain PMA supplements.

Firms must submit PMA supplements prior to making changes that alter the safety or effectiveness of their devices, the guidance says -- unless certain exceptions apply. Modifications requiring a supplement include changes to a device's indications, labeling, sterilization procedures, expiration date or packaging.

The agency provides guidance for determining the type of PMA application (e.g., original, panel-track supplement, 180-day supplement, real-time supplement and/or special PMA supplement) required if a company modifies the design or labeling, manufacturing process, manufacturing location or packaging of a device. The guidance also gives examples of modifications, descriptions of the testing to support these changes and the types of PMA applications that were submitted for them.

The document, "Draft Guidance for Industry and FDA Staff -- Modifications to Devices Subject to Premarket Approval (PMA) -- The PMA Supplement Decision-Making Process," replaces the draft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

( http://www.fdanews.com/ddl/34_12/ )