Medmarc Blog (blog.medmarc.com)
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...
FDA Revisits Intended Use Rule
The FDA’s policy for determining a manufacturer’s intended use has strained relations between the agency and industry in the past, but the agency said in a press release that the latest version...
CMS Floats Coverage Policy for Breakthrough Devices
The Centers for Medicare & Medicaid Services recently unveiled a new plan to offer four years of Medicare coverage for any medical devices cleared or approved through the FDA’s breakthrough...
HHS Orders FDA to Stand Down on LDTs
The Department of Health and Human Services issued an Aug. 19 rescission order to the FDA directing the agency to cease requiring any premarket reviews for lab-developed tests (LDTs), a change...
FDA Releases Final Guidance for Multiple Function Devices
After a wait of two years, the FDA has concluded the draft guidance for multiple function devices with a final version that makes several substantive changes. Among these is that the list of...