Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Elizabeth Orr
BIO and AdvaMed offered multiple concerns about a January US FDA draft guidance formalizing the pre-RFD process, including that the timeline is too long and that the recommended information may not land manufacturers a center designation.
Most stakeholders speaking and participating in panels during the Federal Trade Commission’s April 18 workshop on hearing aids expressed support for over-the-counter sales of the devices, though several expressed reservations about how to best protect patients.
The US Federal Trade Commission plans to discuss hearing-aid marketing rules at an April 18 workshop. The workshop joins other recent government efforts, including a Senate bill and a US FDA draft guidance document, to grapple with a 2015 report by the President’s Council of Advisors on Science and Technology that found cost and regulations blocked many patients with hearing loss from getting help.
Halyard Health plans to appeal the verdict, which stems from allegations the company and its former parent, Kimberly-Clark, fraudulently promoted surgical gowns as offering more protection than they really did.
Make pre-submissions early and as complete as possible to ensure speedy review and thorough answers for neurological devices, FDA staff says.
The decision is a coda to a 2014 Federal Circuit verdict that an implantable cardioverter defibrillator patent held by Mirowski Family Ventures was invalid. About $6m in attorney’s fees were at stake.