FDAnews Device Daily Bulletin

Devicemakers praised FDA efforts to craft guidance on the agency’s refuse-to-accept policy for 510(k) premarket notification submissions, but took issue with many specifics, including what would happen if a backlog causes the FDA to miss its proposed 15-day timeline.

A newly proposed EU regulation on in vitro diagnostic medical devices seeks to align IVD classification with the Global Harmonization Task Force’s risk-based model — a move that could place new requirements on the majority of current Class A IVDs by bumping them up to Class B.

A new excise tax will be levied on medical devices beginning Jan. 1, and the impact will be significant for medical device companies with a Memphis presence.

For most people, computer security means just that: Keeping viruses off your desktop or laptop, your PC or your Mac.

The Federal Circuit upheld a $31 million win for Energy Transportation Group on Friday in a suit against William Demant Holding A/S and Widex A/S over two patents related to reducing feedback in digital hearing aids, rejecting the defendants’ bid to reduce the damages award.

Use of a novel transdermal contraceptive patch suppresses ovulation in obese and nonobese women, research shows.

Cleveland Clinic Innovation Centre’s strategic alliance with i360medical builds on Irish medtech growth.

In what could be Australia’s largest class action of its kind, medical company Johnson & Johnson faces a case around one of their products, with wider questions about the approvals process also being asked.