FDA regulations categorize medical devices into three classes, with varying levels of control to manage risks and ensure the safety of medical technologies.

Michelle Tarver, MD, PhD, a 15-year veteran of the agency, is stepping into a pivotal role as the new director of the FDA's device division, taking over for Jeffrey Shuren, MD. Dr. Shuren's tenure was ...

Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five ...

As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...

Tarver, an ophthalmologist, replaces longtime CDRH Director Jeff Shuren, who announced his retirement in July.

As pharmaceutical companies strive to expand access to medications in emerging markets, low-cost, easy-to-use drug delivery ...

At a public forum last week, Peter Marks, the top vaccine regulator for the Food and Drug Administration, said the way to counter the movement is by being transparent. “We have to be steadfast ...

and devices under the Medical Device Regulation (MDR). The EMA has been careful in ensuring that drugs on periodontal ...

The Drug & Alcohol Clearinghouse-II regulation requires State Driver Licensing Agencies (SDLAs) to remove commercial driving privileges from truck drivers with a “prohibited” status in the ...

While macOS does include a PDF editor in its Preview app, iOS devices don’t have a native PDF editor and PDF Expert fills that gap nicely. It has a clean and intuitive interface and offers a ...

The US’ Food and Drug Administration (FDA) has approved Journey Medical’s Emrosi, the brand name for its 40mg minocycline hydrochloride extended-release capsules, to be used in the treatment ...