comprehensive -WSS

comprehensive

author：leisure time 2025-09-03 03:23:51 - browse：74

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： How one medical school became remarkably diverse
Next article： Google's generative AI to analyze medical images — and talk to docs

WSS

Brain 'hot spot' may explain why African Americans feel greater pain

Grail is spending more than ever lobbying Congress

Doctors push to include dialysis machines in emergency stockpile

Democrats are overperforming in 2023's special elections. Is it a clue for Biden vs. Trump?

Listen: Biogen's messy board & Laronde's data problem

Can food be medicine? And other questions about a new push

hotspot

comprehensive

hotspot

Medical records are filled with copy

7 people shot in DC, police say

Medicare proposal to cover medical devices draws a mixed reaction

Can food be medicine? And other questions about a new push

Supreme Court strikes down use of affirmative action

A fugitive mob suspect in Greece is betrayed by his passion for hometown Naples soccer champions

Medicare proposal to cover medical devices draws a mixed reaction

Kansas bar where gunfire wounded 9 last month closes permanently

Continuity nursing helped my family in our darkest PICU moments

Bacterial infection may be ‘key event’ in endometriosis, study says

focus

Doctor appointment wait times are getting worse

Doctors push to include dialysis machines in emergency stockpile

Feed a cold, starve a fever? Here’s what science says

4th of July breaks record for highest global temperature ever measured

Meta looks to target Twitter with a rival app called Threads

Judge in Trump's classified documents case questions use of out

focus

leisure time

Wikipedia

knowledge