Regulatory and Compliance
Feb 23, 2017
Cybersecurity is a concern for connected medical devices, but not all risks are apparent—or materialize—until after a product is on the market. FDA therefore...
Feb 22, 2017
An expert discusses what medical device manufacturers need to keep in mind as the compliance date for the fourth edition of the IEC 60601-1-2 standard...
Feb 03, 2017
Marie Thibault In what is a significant step for the effort to add unique device identifiers (UDIs) to health insurance claims forms, on February 1 the...
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CDRH has publicized its resolution list for the new year, issuing an A-list of its top priorities for final and draft guidance in fiscal year...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Marie Thibault Almost a year after its draft guidance proposing public notification of emerging signals for postmarket medical devices, FDA is issuing final...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...