Senate Republicans want answers from FDA commish Hamburg on draft guidances
May 8, 2014 by Brad Perriello
Four Republican senators are asking FDA commissioner Dr. Margaret Hamburg for some answers on the federal watchdog agency’s practice of issuing draft guidances to cover medical device and drug review policies.
In the May 6 letter the legislators – Sens. Lamar Alexander (R-Tenn.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.) and Orrin Hatch (R-Utah) – say they’re concerned that the draft guidances are being used by the FDA “to make substantive policy changes.” Read more
Medtech regulation: FDA releases April 2014 510(k) decisions
May 8, 2014 by Brad Perriello
April 2014 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2014
TOTAL 510(k)s THIS PERIOD 268
TOTAL WITH SUMMARIES 250
TOTAL WITH STATEMENTS 18 Read more
Prosthetic arm that translates muscle signals into action wins FDA approval
May 9, 2014 by Brad Perriello
The FDA today said it will allow the 1st prosthetic arm to translate muscle signals into action onto the U.S. market under its de novo protocol for innovative devices. The prosthesis, called the DEKA arm system, was developed by inventor Dean Kamen’s DEKA Integrated Solutions.
The DEKA arm “can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes,” the FDA said. The electrodes sense electrical activity in muscles near the prosthesis and send signals to a processor that translates them into movement, according to a press release. Read more
FDA warns Cook Medical on unapproved changes to Evolution lead extractor
May 7, 2014 by Brad Perriello
The FDA last month accused Cook Medical of selling an unapproved device in the U.S., saying changes made to Cook Vascular’s Evolution RL cardiac lead extraction device require the medical device company to file a new clearance application with the watchdog agency.
“The United States Food & Drug Administration (FDA) has learned that your firm is marketing the Cook Evolution RL and the Shortie RL Bi-directional Dilator Sheath Sets in the United States without marketing clearance or approval,” according to the April 25 letter, which the FDA posted online May 5. Read more
FDA: Foreign medtech firms receive excess manufacturing violations
May 6, 2014 by Arezu Sarvestani
FDA inspectors have stepped up their surveillance of foreign medical device manufacturers, finding that they make up a disproportionate number of process and quality violations that result in formal warning letters.
Foreign firms accounted for about 10% of inspections conducted in 2012 but received 40% of the FDA warning letters. China alone was responsible for 12% of all the quality systems warning letters issued that year. Read more