Regulatory and Compliance
Jan 03, 2017
Device manufacturers may find themselves advocating equivalence to FDA for the 510(k) process while also differentiating their product from the same device in...
Dec 29, 2016
Marie Thibault CDRH has publicized its resolution list for the new year, issuing an A-list of its top priorities for final and draft guidance in fiscal year...
Dec 16, 2016
Considering what FDA and medtech regulation may look like under the incoming administration. Jim Dickinson Emerging like the campaign that preceded it as the...
Dec 16, 2016
In the second installment of this three-part article series, experts discuss federal initiatives regarding medical device postmarket surveillance and set out...
Dec 13, 2016
Marie Thibault Almost a year after its draft guidance proposing public notification of emerging signals for postmarket medical devices, FDA is issuing final...
Dec 13, 2016
In the first installment of this three-part article series, experts detail the requirements for complying with medical device postmarket surveillance...
Dec 11, 2016
In the final installment of this three-part article series, experts explain the legal issues surrounding medical device postmarket surveillance. Kevin Ong, PhD...
Dec 09, 2016
These were the most important guidance documents of the year for medical device manufacturers. Gordon MacFarlane, PhD, RAC and Cynthia Nolte, PhD, RAC This...
Dec 07, 2016
FDA announces it will consider creating a class of over-the-counter hearing aids and will remove certain requirements in order to make the devices easier to...
Dec 06, 2016
Marie Thibault U.S. Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) recently introduced bipartisan legislation to make some kinds of hearing aids...