In an exclusive interview with Medtech Insight, FDA device center director Jeff Shuren wouldn’t commit to meeting the agency’s internal deadline of April for putting out a draft version of its revised Quality System Regulation, which will be harmonized with international standard ISO 13485. Instead, he would only say that the rule would likely be out “sometime” in 2020. Shuren added that the FDA wants to “hit the ground running” when the new QSR is eventually finalized.
It looks increasingly unlikely that the US Food and Drug Administration will meet its own April deadline for releasing a draft version of its updated Quality System Regulation.
The FDA has been working on harmonizing its QSR with international quality systems standard ISO 13485 since mid-2018. A draft...
"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.
16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.
Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.
