He noted that the hiring of FDA device reviewers is largely financed through an ongoing five-year agreement between the FDA and medical device companies.

He noted that the hiring of FDA device reviewers is largely financed through an ongoing five-year agreement between the FDA and medical device companies.

Recalled heart devices often do not go through clinical testing, a new study found, highlighting growing concerns about the FDA’s medical device approval standards.

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s ...

SBOMs And Medical Device Cybersecurity Premarket submissions to the FDA for medical device approval now require the inclusion of an SBOM.

With medical devices, recalls are not always what they seem. In some recalls, including some of the most serious, the FDA and the manufacturers let doctors and hospitals continue to use the devices.

The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...

He noted that the hiring of FDA device reviewers is largely financed through an ongoing five-year agreement between the FDA and medical device companies.

The oversight of medical device products has held a place on the watchdog’s high-risk list since 2009. “We have previously reported on challenges FDA has faced in its oversight of the safety of ...

Beginning Friday night, FDA employees overseeing medical devices, food ingredients and other key areas received calls and emails notifying them that their recent terminations had been “rescinded ...

He noted that the hiring of FDA device reviewers is largely financed through an ongoing five-year agreement between the FDA and medical device companies.