FDAnews Device Daily Bulletin

CDRH APPROVES 38 NEW PMAS IN 2005, RECALLS 437 DEVICES

April 3, 2006
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The FDA approved 38 premarket applications (PMAs) for new devices in 2005 and cleared 2,617 510(k) submissions for products with prior uses, the agency announced recently.

The most innovative products approved in 2005, according to the FDA, were: DuraSeal dura sealant system, the first approved material for sealing leaks in the dura mater covering of the brain; invader UGT1A1 molecular assay, the first DNA-based test providing genetic information for personalized treatments; VeriChip implantable RF transponder system, an implantable chip for maintaining patient medical data; Syncardia temporary CardioWest total artificial heart, a device for patients at risk of imminent death from heart failure while awaiting a heart transplant; and CoAxia neuroflo catheter, a device to treat insufficient blood flow to the brain.

The number of original PMAs, investigational device exemptions (IDEs) and 510(k) submissions has remained relatively stable since 2000 with some fluctuation, according to agency reports. In 2004, the agency received 51 original PMAs compared to 54 in 2003. Similarly, the FDA received 226 IDEs in 2004 compared to 242 in 2003.