Oct. 16, 2024 — Before the FDA allows prescription medicines on the market, drugmakers must prove they’re safe and effective. What’s less widely known is that most medical devices ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now ...

FDA staffers said entire teams of five or more medical device reviewers had been reinstated. There did not appear to be a similar effort to rehire staffers in other parts of the agency, including ...

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...

The FDA hasn’t released official numbers on the terminations, but former FDA officials have pegged the number at roughly 700, with more than 220 coming from the medical device center.

8/12: CBS News 24/7 Episode 2 43:20. In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — "a Class I recall, the most serious type," the FDA said. "Use of this ...

The GAO report states in a footnote that the “FDA did not make a similar request in the agencies’ FY2025 budget justifications.” Meanwhile, the FDA told the GAO that by December, it plans to begin ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s ...

The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...