WASHINGTON – A subcommittee of the House Energy and Commerce (E&C) Committee needed little time to agree to the manager's mark for the House version of FDA user fee legislation, amending the draft with only a technical fix offered by the subcommittee chairman.
The demise of the Global Harmonization Task Force as a regulator-plus-industry forum for harmonization – or “convergence,” as the cautiously optimistic like to say – was met with little more than silence from the trade associations, but one can be sure the off-the-record discussions were intense. Now with the International Medical Device Regulators Forum coming together, the time has come to ask what the future of international medical device regulation holds. First let’s examine the obvious. The chatter about demonstrations of efficacy as a requirement for a CE mark has been going on for some time, and the flap over...
GAITHERSBURG, Maryland The age of the truly leadless implantable defibrillator may be years away, but the advisory committee hearing for the implantable cardioverter defibrillator sponsored by Cameron Health (San Clemente, California) suggests that the age of the transvenous electrophysiology lead may be a thing of the past in the not-too-distant future.
