hotspot -WSS

hotspot

author：Wikipedia 2025-09-30 14:08:42 - browse：9634

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： FDA approval of Sarepta Duchenne genetic therapy gives me hope
Next article： The stability of $0 premiums in Medicare Advantage

WSS

Involuntary treatment for addiction doesn't work

Stop Congress from blocking public access to science

Experts study whether long Covid risk adds up with each reinfection

Medicare innovation center doesn’t save money, experts say

Does aspartame cause cancer? What new WHO guidance says

WHO recommends second malaria vaccine

entertainment

hotspot

Wikipedia

DIEP, the 'gold standard' of breast reconstruction, is under threat

6 solutions to address cancer drug shortages and others

Drug repurposing or repositioning? The language matters

6 solutions to address cancer drug shortages and others

Sports medicine is finally prioritizing gender equality

RSV injection headlines need to be accurate for good uptake

Drug repurposing or repositioning? The language matters

Global childhood vaccinations edge closer to pre

The cancer drug shortage isn’t new — and neither are the solutions

Elon Musk says Twitter has 'negative cash flow' and 'heavy debt'

Wikipedia

Care demand spikes challenge UnitedHealth’s provider arm

Care demand spikes challenge UnitedHealth’s provider arm

The stability of $0 premiums in Medicare Advantage

Elon Musk says Twitter has 'negative cash flow' and 'heavy debt'

Why police arrested suspected Gilgo Beach killer away from his house

The stability of $0 premiums in Medicare Advantage

entertainment

focus

hotspot

focus