hotspot -WSS

hotspot

author：knowledge 2025-09-30 20:17:48 - browse：4

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： Drug repurposing or repositioning? The language matters
Next article： WATCH: Why do our ears pop?

explore

WSS

A new drug could help frostbite victims avoid its ravages

UnitedHealth’s board chair also owns a personal investment firm

UnitedHealth’s board chair also owns a personal investment firm

Reporting on presidential health from Reagan to Trump and Biden

New study raises questions about niacin and heart health

Medicare reduced heart disease by changing how it pays doctors

knowledge

hotspot

focus

Biden outlines 'new path' to provide student loan relief after Supreme Court rejection

Eli Lilly expects to double planned employment in Boston center

FDA approval of Sarepta Duchenne genetic therapy gives me hope

2023 STAT Wunderkinds: get to know the winners

Sports medicine is finally prioritizing gender equality

How climate

The Supreme Court will review a ruling striking down a domestic violence federal gun ban

The EU Joint Clinical Assessment needs to live up to its promise

Sports medicine is finally prioritizing gender equality

STAT Summit: GSK CEO on pharma giant's new direction

hotspot

Medicare reduced heart disease by changing how it pays doctors

Abridge raises $150m as clinical notes automation market heats up

Pharmacists can make shortage drugs, but at what cost?

Researchers explore possible ties between long Covid, menopause

Medicare reduced heart disease by changing how it pays doctors

Researchers tackle phage therapy hurdles for wider adoption

explore

hotspot

hotspot

focus