CDRH’s plans for a specialized pathway for high-risk PMA devices that address unmet medical needs will be modeled on the drug center’s recently established breakthrough therapy pathway, and also the device center’s Innovation Pathway.
The newly planned accelerated PMA pathway for high-risk medical devices that address unmet medical needs will be modeled off of the Center for Drug Evaluation and Research’s breakthrough therapies accelerated pathway, as well as the device center’s Innovation Pathway, according to CDRH Director Jeffrey Shuren.
The CDER breakthrough drug therapy pathway was mandated by the FDA Safety and Innovation Act in 2012. CDER can designate...
Despite a surge in product recalls across five key industries in the first quarter of the year, medical device recalls were down, according to Sedgwick’s latest recall index. But the firm noted they’ve since ticked up.
A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.
Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.
The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.
