Latest From Elizabeth Orr
Medical device companies – including Sientra, Endologix and Invacare – won loans from the US government’s Paycheck Protection Program, intended to protect jobs during the coronavirus pandemic. In total, nearly 1,400 device makers collected as much as $1.6bn, according to a Medtech Insight analysis of PPP data.
The US FDA released five device-related close-out letters in June. An additional close-out letter, dated February 2017, was published for the first time recently due to an agency oversight.
The US FDA has authorized marketing of a combination diagnostic that can detect either COVID-19 or influenza. The agency hopes to encourage development of additional similar tests before the fall flu season.
Medical supplies distributor eSutures is facing a federal injunction over allegations the vendor sold counterfeit surgical supplies purportedly made by Johnson & Johnson unit Ethicon.
A recent Supreme Court decision that set limits on the SEC’s ability to collect ill-gotten profits could also bring change to FDA policies, according to experts.
A newly finalized FDA guidance on device firm inspection procedures recommends a five-day advance warning, three- to six-day inspections and lots of verbal communication throughout the process.