government regulation
Ben Wolf, partner in Alston & Bird's Health Care Group, told MobiHealthNews how FDA staffing cuts could slow device approvals and what companies can do to stay ahead.
The judge ruled that the FDA overstepped its authority by regulating LDTs as medical devices, overturning the rule and remanding it to the HHS Secretary for review.
The bill would allow AI to be classified as a "practitioner licensed by law" to administer FDA-approved drugs.