Capturing and analyzing product quality data appears to be a hiccup for many firms, but the problem can be addressed through the use of proper tools and effective monitoring of quality data sources, FDA officials explain. When quality data is added to a manufacturer’s CAPA system and properly analyzed, device problems may be discovered more quickly. Further, firms that inadequately define data sources in their procedures and mishandle information coming out of those sources will attract the notice of FDA investigators. “I would urge you to sit down with the investigator and show them your quality data elements and where the data is coming from, as well as how that information is analyzed,” said Phil Pontikos, FDA’s national expert on medical devices. “If you share those processes upfront, I think it will help expedite the inspection.”
Many device manufacturers aren’t doing a good job of capturing and analyzing product quality data – a misstep that could lead to FDA regulatory action, agency officials say.
“I’m sure most firms would say they have their quality data sources clearly identified. I’m going to tell you that...
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’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
