Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the ...

Be wary of “FDA Registered” and “FDA Certified” claims ... that the device is comparable to a product the FDA has already carefully vetted. You can do the same for home medical tests ...

The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...

In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the ...

To address these shortages, the FDA has put measures into place, including expedited review processes and the use of enforcement discretion. The FDA also now requires manufacturers to give at least ...

The Dec. 18 letter stated that FDA found ... to support the claim that that spacer material is absorbed by the body." Hologic has received complaints and filed medical device reports to the ...

The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.