Guidance for Submitting PMA Supplements Available

FDA has issued a draft guidance that can help device manufacturers determine if design changes will require a supplemental premarket approval application (PMA).

Entitled "Modifications To Devices Subject To Premarket Approval--The PMA Supplement Decision-Making Process," the draft guidance includes a flowchart model that could be used by PMA holders to analyze whether the changes affect the safety or effectiveness of the device, and therefore, require submission of a new PMA, PMA supplement, alternate submission to a PMA supplement, annual report, or documentation in the PMA holders' files on the device.

The guidance does not apply to combination products, such as drug/device or biologic/device combinations. Three separate flowcharts for in vitro diagnostic devices (IVDs) cover changes in technology or performance, change assessment, and materials changes for IVDs.

The types of modifications addressed in the draft guidance include changes in device design, device labeling, device materials, and the manufacturing process for the device. This draft guidance can also be applied to situations when a legally marketed device is the subject of a recall and a change is indicated to assure the safety and effectiveness of the device.

The document can be viewed on the CDRH home page at http://www.fda.gov/cdrh. For more information, contact Kathy M. Poneleit, Center for Devices and Radiological Health (HFZ-402), FDA, 9200 Corporate Blvd., Rockville, MD 20850; (301) 594-2186. Written comments must be received by November 4, 1998.