May 4, 2021
The U.S. Supreme Court has ruled in a case involving the Federal Trade Commission regarding limits to the agency’s statutory authority to obtain restitution from defendants in a range of enforcement...
April 20, 2021
The FDA has withdrawn a Jan. 15, 2021, rule by the Department of Health and Human Services that had would have exempted more than 80 medium-risk device types from premarket notification requirements...
March 30, 2021
The Department of Health and Human Services posted notice of suspension of the Securing Updated and Necessary Evaluations Timely (SUNSET) rule, which would have required review of HHS agency rules 10...
March 16, 2021
The Centers for Medicare & Medicaid Services has suspended the effective date for the proposed Medicare coverage program for FDA-designated breakthrough devices, temporarily reversing a program that...
March 11, 2021
The news of novel variants of the SARS-CoV-2 virus triggered a response from across the U.S. federal government, but the impact was perhaps most keenly felt at the FDA, which issued multiple guidances...
February 17, 2021
The FDA announced an action plan for artificial intelligence in mid-January, which comes across largely as a follow-up to a discussion paper the agency posted in April 2019. The plan lays out a number...
February 1, 2021
The Biden administration has wasted no time in issuing a number of executive orders (EOs), including those that applied a freeze to or revoked a number of orders issued under the Trump administration....
January 28, 2021
The administrative levers at the U.S. Department of Health and Human Services will change hands shortly, but the current administration has taken two actions that each could have a significant impact...
December 14, 2020
Negotiations are underway between the FDA and industry regarding MDUFA V, the fifth medical device user fee agreement, but there are still some issues with the current agreement. One of those,...
December 4, 2020
The medical device regulatory office for the European Commission (EC) finalized a guidance for risk categorization of in vitro diagnostics (IVDs), but concerns about the related implementation date...
