CBS News

The FDA calls them "recalls," yet the targeted medical devices often remain in use

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 device may cause serious injuries or death ...
STAT

Fixing the reimbursement and coverage divide between ‘breakthrough’ drugs and medical devices

The Food and Drug Administration designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and review of therapies intended to treat serious ...
STAT

Jeff Shuren stabilized the FDA’s medical devices center, winning over industry but not all patients

Retirements from the Food and Drug Administration are hardly shocking, especially in the wake of pandemic burnout. But when longtime medical device director Jeff Shuren announced his departure in July ...
Medical Device and Diagnostic Industry (MD+DI)

Two Key Medical Device Leaders Ditch FDA

FDA loses two key leaders as Jessica Paulsen departs Digital Health Center and David McMullen joins Neuralink amid staffing ...
Becker's Spine Review

Spine implants, tech earning FDA nods in 2025

Here are 40 spine devices and technologies earning FDA clearances in 2025. Note: This is not an exhaustive list. 1. SurGenTec earned FDA 510(k) clearance for its OsteoFlo HydroFiber to be used as a ...
HealthLeaders Media

FDA to Ramp Up Surveillance of Potentially Faulty Medical Devices

More than 1.7 million patient injuries and 83,000 deaths have been linked to defective medical equipment over a 10-year span. The Food and Drug Administration is building a surveillance platform as ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Medical Device and Diagnostic Industry (MD+DI)

How to Navigate the Triad of Audits in Medical Device Compliance

MDR, MDSAP, and FDA audits demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market ...

FDA Rarely Forces Manufacturers to Recall Dangerous Medical Devices, GAO Report Says

The FDA rarely uses its authority to pull dangerous medical devices off the market and is so poorly staffed that it's sometimes unable to make sure companies are taking critical steps to protect ...
The National Law Review

FDA Issues Draft Guidance on Cybersecurity for Medical Devices

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
NBC News

FDA rehires staff to its medical devices division after mass layoffs

The Trump administration is reinstating some employees in the Food and Drug Administration's medical devices division after dozens were laid off as part of a government-wide cost-cutting initiative ...