FDA ANNOUNCES TWO DEVICE ADVISORY COMMITTEE MEETINGS

The FDA has announced that its General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee will meet Aug. 24 and 25. On Aug. 24, the committee will discuss, make recommendations and vote on premarket approval (PMA) applications for an injectable device to correct lipoatrophy of the face -- the loss of fat beneath the skin -- in HIV-positive patients; and for the same device to be used as filler material to restore soft tissue facial contours, the agency said. On Aug. 25, the committee will discuss and make recommendations on the reclassification to Class II of a Class III medical device, cyanoacrylate tissue adhesive.

The meeting notice can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/E6-11775.htm (http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-11775.htm).

The agency has also announced that its Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will meet Aug. 29 to discuss, make recommendations and vote on a PMA application for a noninvasive device for use as a complement to clinical breast examination in asymptomatic women between the ages of 30 to 39.

The meeting notice can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/E6-11773.htm (http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-11773.htm).