A new FDA artificial intelligence tool designed to streamline medical device reviews is faltering in its early rollout stages, raising concerns for agency staff and ethics experts about its ...

Medical device maker ICU Medical changed the designs of infusion pumps made in Minnesota without properly clearing important regulatory checks after a recent recall, according to a Food and Drug ...

"Despite the huge demand for safer nicotine alternatives among adult smokers, the FDA has authorized just eight vaping devices for sale ... Bentley said. Less regulation was also the focus ...

U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical ...

the mindset driven by regulations and best practices has not permeated the industry. Manufacturers and healthcare organizations using devices are both responsible for these lapses. The FDA’s ...

As AI technology evolves rapidly, the FDA is tackling the challenge of balancing innovation with patient safety, shaping regulations that ensure AI tools remain effective throughout their entire ...

Under this law, medical device companies pay fees to the FDA for regulatory services, which gives them influence over the process, Redberg said. “The [device] companies dictate that the FDA ...

The Food and Drug Administration (FDA) has formed a task force assigned to improve regulation of medical devices in the country. The Task Force Obsidian was established to help stakeholders identify ...

Regulation during a rapid proliferation of AI medical devices Following the rapid proliferation of these devices and applications to the FDA, Chouffani El Fassi and Henderson et al. were curious ...

Our findings suggest that physicians commonly lack familiarity with drug and medical device regulatory practices and are under the impression that the data supporting FDA drug and high-risk device ...

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