June 17, 2021
The FDA has issued final guidance for testing and labeling medical devices for safety in the magnetic resonance environment. This guidance will be essential for manufacturers of both implantable...
June 2, 2021
CMS Adds Administrator, Hits Pause on MCIT The Center for Medicare & Medicaid Services has a new administrator, Chiquita Brooks-LaSure, signaling an end to a leadership void at an agency that is...
May 17, 2021
The FDA has provided an overview of the impact of the COVID-19 on its inspectional regime for drugs, devices and biologics, which seriously impeded inspections of all but top priority manufacturing...
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The FDA has withdrawn a Jan. 15, 2021, rule by the Department of Health and Human Services that had would have exempted more than 80 medium-risk device types from premarket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....
