knowledge -WSS

knowledge

author：Wikipedia 2025-09-28 18:57:24 - browse：914

empty test tubes in the hand. -- first opinion coverage from STAT — Adobe

The Food and Drug Administration on Friday announced its intention to start regulating tests developed in laboratories — closing the “Theranos loophole” that has allowed inaccurate tests to slip through the cracks.

Lawmakers came close last year to passing a bill that would have given the FDA this authority, but it was ultimately rejected by Republicans who sympathized with the labs in academic medical centers and hospitals that opposed the provision. FDA Commissioner Robert Califf said at the time that if the bill failed, the agency would take matters into its own hands.

The proposed rule fulfills that promise, adding lab diagnostics to the list of devices that fall under FDA enforcement — a move that patient groups and non-lab test makers support, and that laboratories are likely to dispute. When the FDA started regulating medical devices in 1976, lab-developed tests were simple and offered mostly to local patient populations. The agency generally allowed labs to use these tests without submitting proof of their efficacy.

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

Subscribe Log In

Previous article： Guidelines to prevent youth baseball injuries need more muscle
Next article： The strategy behind pharma's lawsuits over drug pricing reform

WSS

Why drug prescriptions should include diagnoses

US recommends Americans reconsider traveling to China due to arbitrary law enforcement, exit bans

#NeedHerScience: shining a light on gender disparities in medicine

Why drug prescriptions should include diagnoses

The Democratic Party promised to overhaul its primaries. Doing that has been anything but simple

Chicago flooding is stark reminder of vulnerability of major cities during extreme weather

explore

knowledge

focus

Moonlake's readout produced a cash windfall. Risks remain

ThunderShirts, dance parties and anxiety meds can help ease dogs' July Fourth dread

Moonlake's readout produced a cash windfall. Risks remain

July 4th fireworks can be stressful for dogs. These 6 tips can keep them calm and safe

United colonoscopy coverage change 'may cost lives,' doctors say

Death of patient in Alzheimer’s trial raises question of possible risks

George Santos makes 1st court appearance after pleading not guilty to 13 counts

Brazil's Neymar fined $3.3 million for illegal artificial lake at mansion outside Rio

Cancer drug shortages should be causing more outrage

Death of patient in Alzheimer’s trial raises question of possible risks

hotspot

Elon Musk announces 'temporary limits' for reading Twitter posts

New guidelines on severe brain injury complicate already difficult decisions

Death of patient in Alzheimer’s trial raises question of possible risks

What would happen to your eyes if you looked at the solar eclipse?

With FDA staff opposed to Sarepta therapy, top official intervened

STAT's guide to the next generation of CAR

knowledge

explore

knowledge

hotspot