Under the US FDA’s voluntary 510(k) Sterility Change Master File Pilot Program, nine firms will be selected to send to the agency updated master files that detail novel sterilization processes without the need to submit a new 510(k). The goal is to move industry away from using ethylene oxide (EtO) to sterilize devices.
Makers of single-use 510(k) medical devices that use ethylene oxide (EtO) to sterilize already-marketed products would be able to switch their method of sterilization with greater ease thanks to a new pilot program announced by the US Food and Drug Administration on 19 May.
Under the voluntary 510(k) Sterility Change Master File Pilot Program, nine firms will be selected to send the FDA updated...
"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.
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.
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.
