The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former ...

Teams working on device communications and policy were cut from the agency on Tuesday, according to multiple FDA workers.

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...

The FDA finalized a rule to oversee lab-developed tests as if they were medical devices, prompting lawsuits. Opponents said ...

"The ongoing gutting of the FDA is likely to cause American deaths," said the CEO of one medical device developer.

The Food and Drug Administration, which oversees medical devices, has 3,500 jobs on the chopping block — which could hinder ...

The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...

A federal judge in Texas has ruled that the FDA does not have the authority to regulate laboratory developed tests as medical ...

Around 3,500 employees are on the chopping block at the FDA, but they don't yet know who they are. The Health and Human Services Department on Thursday announced a sweeping plan to cut 10,000 jobs and ...

WASHINGTON -- The Food and Drug Administration’s chief tobacco regulator has been removed from his post amid sweeping cuts at ...

There are a broad range of medical devices that may be vulnerable to cybersecurity breaches, said Rep. Gary Palmer (R-Ala.), ...