hotspot -WSS

hotspot

author：leisure time 2025-09-27 12:34:37 - browse：7528

insulin biosimilar — Last week, the FDA released a trio of guidelines clarifying the way they plan to evaluate devices that go through the 510(k) pathway. Jacquelyn Martin/AP

Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, the Food and Drug Administration has issued new guidelines to improve its so-called 510(k) program that has long been lambasted for letting risky devices fall through the cracks.

Most medical device companies do not have to test their products on people in order to secure clearance from the FDA — they simply have to show they’re “substantially equivalent” to devices already on the market, called “predicates.” This process is the 510(k) pathway, and accounts for the vast majority of new medical devices launched on the market each year. Devices cleared through this pathway include X-ray machines, muscle stimulators, and wheelchairs.

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 that were recalled due to a “design-related” issue or have “unmitigated” safety concerns. Manufacturers should submit flow charts explaining why they chose their predicate device. If they have to choose one with a recall history or safety issues, they should explain how the new device addresses those problems. The FDA may also ask the manufacturer for clinical data in this case.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Virginia high school admissions case could be legal follow
Next article： Doctors find melanoma drugs effective against rare brain cancer

WSS

FDA poised to publish guidelines for clinical trial diversity

FDA moves to stop vape shops from selling Elf Bar, Esco Bars

Key House panel plots a new health care package

Biden tests positive for Covid

Custom gene therapy hints at new path for rare disease treatments

STAT Virtual Event: The State of Biosimilars: What to Watch

explore

hotspot

entertainment

Peter Hotez and the public health issue of online harassment

Cosmetics set for new safety regulation. Why the industry is on board

After affirmative action ruling, medical educators look to 'holistic review'

UnitedHealth argues against case alleging wrongful AI care denials

Jerome Adams on the need for new antivirals for Covid

Group opposing PBM reform sets lobbying record

Drug repurposing or repositioning? The language matters

ARCH Venture Partners tops STAT's 2023 biotech VC rankings

Medicare details structure of new drug price negotiation program

Listen: Wegovy in the brain & pivotal Alzheimer's data

focus

Key House panel plots a new health care package

Fentanyl is making it harder to start addiction treatment

Investigation reveals sickle cell patients pressured into sterilizations

H5N1 bird flu outbreak: Second human case reported, in Michigan

STAT Virtual Event: The State of Biosimilars: What to Watch

Key House panel plots a new health care package

leisure time

entertainment

hotspot

knowledge