Medmarc Blog (blog.medmarc.com)
CMS Suspends MCIT Start Date
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...
FDA Reacts to COVID Mutations
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...
FDA Releases Action Plan for AI
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...
Biden Administration Revokes Series of Executive Orders
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...
HHS Posts Civil Enforcement, Regulatory Review Mandates
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...
Industry: FDA Staffing a Key User Fee Issue
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,...
EU releases IVD Risk Classification Framework
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...
HHS Proposes Decennial Review of Regulations
The U.S. Department of Health and Human Services posted a notice of proposed rulemaking requiring HHS agencies to periodically assess their regulations to determine whether a regulation is...
HHS Announces Delayed HIT Compliance Deadlines
The Department of Health and Human Services has responded to concerns about compliance dates for healthcare IT with an interim final rule that relaxes those deadlines by nearly half a year....
FDA Closes EUA Program to Lab-Developed Tests
The question of whether the FDA has the authority to regulate lab-developed tests (LDTs) boiled into plain view in August when the Department of Health and Human Services directed the agency to...