Regulatory and Legal
May 20, 2015
Marie Thibault FDA has tried to tackle the dilemma of off-label use of medical devices in children by giving industry guidance on extrapolating adult clinical...
May 18, 2015
Marie Thibault The long shelf life and uncommon business model of orthopedic implants is presenting a hitch in implementing FDA's Unique Device Identification...
May 14, 2015
Marie Thibault   The House of Representatives Energy and Commerce Subcommittee on Health is charging ahead on the proposed 21st Century Cures legislation...
May 13, 2015
Marie Thibault   FDA is showing that it takes patient input and preferences seriously, by giving the medical device industry new draft guidance on the...
May 11, 2015
Marie Thibault CDRH should have no shortage of training opportunities for its medical device reviewers, as several medical device companies have offered to...
May 07, 2015
Marie Thibault   FDA has thrown out 47 of its draft guidance documents, terming them outdated due to "new information, scientific developments, and...
Sep 22, 2014
Last week ACT | The App Association, a grassroots organization representing mobile app developers sent a letter to congressman Tom Marino (R-PA) petitioning...
Sep 18, 2014
Mobile apps? There's a lobby for that. ACT | The App Association, a grassroots organization representing over 5000 small- to mid-size app developers and IT...
Jun 12, 2014
On Wednesday, Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health took to the agency’s official blog to update the...
May 09, 2014
FDA will allow marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical...