explore -WSS

explore

author：comprehensive 2025-09-30 16:28:17 - browse：526

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： Malaria cases in Florida and Texas: Here’s what you need to know
Next article： Information blocking fines are now fair game in health care

entertainment

WSS

There’s no way to know how good AI health technologies are

Bernie Sanders bashes nonprofit hospitals over their tax breaks

Humana CEO Bruce Broussard to step down in 2024

Covid’s new normal has set in amid another rise in cases

'A game

Information blocking fines are now fair game in health care

hotspot

explore

knowledge

Medicare proposal to cover medical devices draws a mixed reaction

Takeaways from AdvaMed, the largest medical devices conference

Duchenne breakthrough therapy leaves behind pioneering families

Akili changes sales model for its ADHD video game treatment

Affirmative action in medical school literally saved lives

Neurocrine congenital adrenal hyperplasia trial succeeds

Cancer drug shortages should be causing more outrage

What happened to the House vote on health price transparency?

Continuity nursing helped my family in our darkest PICU moments

Free Covid tests will again be offered to all U.S. households

explore

Information blocking fines are now fair game in health care

Massive project maps cells in human brain in unprecedented detail

There’s no way to know how good AI health technologies are

European regulators recommend Amylyx's ALS drug be rejected

People with substance use disorder deserve online privacy

What happened to the House vote on health price transparency?

entertainment

focus

hotspot

hotspot