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FDA, medical device submissions

Tumult in FDA’s medical device center; one CEO speaks out on NIH cuts

The cuts hit the FDA’s medical device center particularly hard, impacting product reviewers and researchers of AI-enabled medical technology. Notably, the center has a strained relationship with one of Musk’s companies, Neuralink, which is testing a brain implant. Read more.

medtechdive · 9h

Device industry scrambles as FDA job cuts cause delays

The cuts at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an attorney said.

Bloomberg on MSN · 1d

Medical Device Industry Protests Firings of FDA Workers

The group that represents medical device makers in Washington is coming out against the Trump administration’s firings of employees who regulate the industry.

FDA, White House and Woman

Reuters on MSN · 10h

Exclusive: FDA staffers told that 'woman,' 'disabled' among banned words; White House says it’s an error

A list with the file name "Prohibited words" has been circulating since at least last week in official work chats, according to two FDA scientists with direct knowledge of the matter.

Washington Examiner on MSN · 7h

White House disputes FDA prohibited words list including ‘women’ and ‘disabled’

Food and Drug Administration staffers were told not to use words like “woman” and “disabled” in work chats for at least the last week, but the White House said this order was erroneous. A White House spokesperson told Reuters that the list of “prohibited words” came from a misunderstanding of President Donald Trump’s executive orders

The Daily Beast on MSN · 10h

FDA Scientists Say They Were Told to Stop Using the Words ‘Woman’ and ‘Disabled’

Scientists at the Food and Drug Administration say they were told to stop using certain words in external communications, including “woman,” “disabled,” and “elderly,” according to a report. Two FDA scientists told Reuters that a file titled “Prohibited Words” showing a list of banned terms was circulated at the agency over the last week.

STAT1d

Health AI: How recent FDA layoffs could shift regulatory burden to health systems

Tech adoption might slow down if the FDA layoffs shift responsibility for medical device and AI safety to hospitals.

JD Supra11h

Foreign Drug and Medical Device Manufacturers Under a Second Trump Administration: Increased Enforcement Scrutiny?

As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, ...

BioPharma Dive9h

In FDA job cuts, experts see threat of far-reaching impact

"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency ...

2don MSN

Exclusive: FDA staff reviewing Musk’s Neuralink were included in DOGE employee firings, sources say

U.S. Food and Drug Administration employees reviewing Elon Musk’s brain implant company Neuralink were fired over the weekend ...

BioSpace11h

FDA Reels From ‘Indiscriminate’ Job Cuts Under Trump as Biopharma Appeals for Clarity

Morale is low at the FDA, which was hit with layoffs this week following RFK Jr.’s confirmation. Biopharma leaders and agency ...

devdiscourse3d

Neuralink Workforce Cut Sparks FDA Concerns

The U.S. FDA recently dismissed employees involved in reviewing Neuralink's brain-computer interface applications, raising concerns about potential delays in medical device processing. The layoffs are ...

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