Mass layoffs at the U.S. Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA), will impact the medical device regulatory process, says Ben Wolf, partner in Alston & Bird’s Health Care Group.
Wolf, an FDA attorney, sat down with MobiHealthNews to discuss how staffing cuts at the Agency could lead to longer review times for medical device approvals...
A federal judge in Texas ruled that the FDA overstepped its authority when it issued its Final Rule: Medical Devices; Laboratory Developed Tests in May of last year, which said laboratory-developed tests (LDTs) should be regulated as medical devices.
In a 450-page lawsuit filed by the American Clinical Laboratory Association (ACLA), molecular testing laboratory for infectious diseases...
Proposed legislation introduced in the U.S. House of Representatives will allow AI and machine learning technology to prescribe drugs approved by the FDA autonomously.
The bill, H.R.238, introduced on Jan. 7, would require amending the Federal Food, Drug, and Cosmetic Act (FFDCA) to "clarify that artificial intelligence and machine learning technologies can qualify as a practitioner eligible, to...
