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 ...

Last week, the FDA released a trio of guidelines clarifying the way it plans to evaluate devices that go through the 510(k) pathway. The agency is asking manufacturers to avoid predicate devices ...

Thousands of devices “The FDA regulates more than 190,000 different devices, which are manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide,” FDA ...

Medical devices like heart monitors, which are under the purview of the Food and Drug Administration, have cybersecurity vulnerabilities that aren’t frequently exploited but nevertheless pose risks to ...

An FDA pathway to clear medical devices is putting patients at risk, research suggests. By Matthew Herper Jan. 10, 2023. Reprints. Adobe. The Food and Drug Administration’s approach to ...

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 ...

The FDA now clears about 3,000 low- to moderate-risk devices every year through 510(k) review, which costs the device maker a standard FDA fee of about $22,000.

FDA anticipates fewer novel medical device approvals in 2022. By Conor Hale Oct 28, 2022 11:03am. FDA COVID-19 Supply Chain medical device. On the backs of a waning COVID-19 ...