The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

FDA Changing Medical Device 510(k) ... with much of what's on the market being based on mesh that was around prior to implementation of FDA regulations for medical devices in 1976.

A new Netflix documentary – The Bleeding Edge – highlights a wide range of systemic flaws in the FDA’s regulation of medical devices. As always, the patient stories are truly heartbreaking ...

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. In 2023, the Food and Drug Administration (FDA) took a more active approach to medical ...

The Food and Drug Administration doesn’t want to take away your Fitbit. That was the philosophy the FDA broadcast earlier this year when it unveiled its “draft guidance” for low-risk medical ...

The "FDA Medical Device Regulation" directory has been added to ResearchAndMarkets.com's offering. The Guide to Medical Device Regulation contains the highest quality analyses on the regulation of ...

For the former guidance, the FDA stresses that some device accessories can have lower risk profiles than their parent devices, which would warrant regulation in a lower class.

The FDA stands as a robust guardian of patient safety and quality standards within the medical device industry. Through stringent regulatory processes, it ensures that only safe and effective ...

In 2008, the FDA released its Medical Device Data System (MDDS) proposal, which is aimed at reclassifying health IT. The proposed regulation would define medical devices as anything that provides ...

This article was originally on a blog post platform and may be missing photos, graphics or links. See About archive blog posts. The Food and Drug Administration has introduced a proposal that ...