NEW YORK (Reuters Health) – Information on the safety and effectiveness of medical devices before and after they are cleared by U.S. health regulators can be improved, according to 2 new studies.
The FDA’s decision to ban so-called "split predicates" in medical device 510(k) applications was met largely with praise from members of the Medical Devices Group on LinkedIn.
A few voices in the crowd expressed concern or ambivalence about the decision, but most commenters agreed that the change "makes sense and seems fair."
Federal medical device regulators finalized a new guidance this week that prohibits manufacturers from using so-called "split predicates" to establish that their new products are effectively the same as devices already on the market.
Federal medical device regulators issued new draft guidance this week hoping to clarify the agency’s process for determining the benefits and risks of 510(k) devices.
The new guidance wouldn’t change any of the FDA’s existing policies for evaluating 510(k) submissions, but the agency hopes the document will help device makers better understand the agency’s thinking.
Medical device makers lauded the FDA this week for policy proposals that would leave existing 510(k) modification rules generally intact, rather than pursuing the overhaul proposed 3 years ago.
Superstar medical device inventor and industry legend Dr. Thomas Fogarty may have ended up in a very different place had he come up under today’s FDA.
By Stewart Eisenhart, Emergo Group
Healthcare industry analysts at PricewaterhouseCoopers’ Health Research Institute have a few lessons for companies navigating what promises to be a turbulent year ahead, offering advice ranging from failing frugally to adapting to heightened transparency expectations.
Here are 3 of the most relevant foresights for the medical device industry, selected from HRI’s top 10:
MASSDEVICE ON CALL — Medical device makers celebrated the FDA’s decision to, for the 1st time, adopt industry-driven interoperability standards, which may help ease the regulatory pathway to 510(k) clearance for data-sharing products, including smartphone accessories.
The FDA is ready to take a closer look at medical device cyber-safety, asking companies to provide details on anti-virus protection and other elements of digital security for new healthcare technologies. In light of a growing concern over incidents in which compromised security has exposed or disabled medical devices, the agency hopes to "reduce the risk of failure due to cyber-attack."