focus -WSS

focus

author：entertainment 2025-09-07 21:55:03 - browse：62

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： DIEP, the 'gold standard' of breast reconstruction, is under threat
Next article： FDA approves first blood sugar monitor without finger pricks

focus

WSS

PlayStation controller and acoustic messaging: How the missing Titanic tourist sub works

Clinic falsely told dozens they had Alzheimer's, suits say

Trump pressured former Arizona governor to overturn 2020 election results: Sources

Trump pressured former Arizona governor to overturn 2020 election results: Sources

Masked assailants attack a journalist and a lawyer in Russia's Chechnya province

Clinic falsely told dozens they had Alzheimer's, suits say

explore

focus

hotspot

Virginia high school admissions case could be legal follow

US judge blocks portions of new Florida elections law

Moonlake's readout produced a cash windfall. Risks remain

PlayStation controller and acoustic messaging: How the missing Titanic tourist sub works

At least 13 dead in Texas as scorching temps continue

Woman found dead after suspected bear encounter near Yellowstone, wildlife officials say

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

Legitimacy of 'customer' in Supreme Court gay rights case raises ethical, legal flags

Psychedelics group wrestles with new pharma identity

FDA approves first blood sugar monitor without finger pricks

focus

New requirements coming in 2024 for Americans traveling to Europe

Clinic falsely told dozens they had Alzheimer's, suits say

Churchill Downs extends trainer Bob Baffert's ban through 2024

Novartis develops a rapidly manufactured CAR

1 dead, 9 hurt in July 4th fireworks explosion

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

focus

focus

knowledge

explore