• Legislators Call for Publicly Available 510(k) Database to Address 'Loophole'

    Two legislators have written to the US Food and Drug Administration's (FDA) top medical device regulator, calling on the agency to provide for public access information about medical devices cleared through FDA's 510(k) premarket notification process. The letter , sent 15 August by Rep. Edward Markey (D-MA) and Sen. Jeff Merkley (D-OR), observes that several medical devices once cleared through the 510(k) process have been subject to high-profile safety concerns and rec...
  • As St. Jude Spat Escalates, FDA Looks to Additional Device Surveillance

    A spat involving St. Jude Medical and the medical journal HeartRhythm escalated sharply on 10 April, with HeartRhythm rebuffing St. Jude's requests to retract an article implying defibrillator leads on St. Jude's Riata products were less safe than previously known, reports various sources. St. Jude had previously released a press release on 6 April calling on the journal to retract the article in light of what it said were "numerous mistakes and oversights," repo...
  • Bill Would Address Medical Device Safety By Giving FDA Additional Authority

    A new bill introduced in the Senate would address medical device safety by giving the US Food and Drug Administration (FDA) additional authority to conduct postmarketing surveillance. "Strong post-marketing surveillance of medical devices will ensure that those that are defective or cause harm can be quickly identified, patients and their physicians can be notified, and dangerous products can be removed from the market," said Senator Jeff Merkley, the bill's chief sponso...