Medmarc Blog (blog.medmarc.com)
FDA (12)
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,...
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 | Medmarc
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After a wait of two years, the FDA has concluded the draft guidance for multiple function devices with a final version that makes several substantive changes.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...
FDA to Resume Domestic Device Inspections
The FDA was forced to announce in March 2020 that it would suspend inspections of drug and medical device manufacturing sites because of the COVID-19 pandemic, but the agency has partially...
FDA Sets 50% Efficacy Benchmark in Vaccine Guidance
The FDA has released a guidance for development of vaccines in response to the COVID-19 pandemic, which among other things suggests the agency will push harder to ensure that any such studies...
The PREP Act and the Revocation of an Emergency Use Authorization
In recent weeks, the FDA has revoked Emergency Use Authorizations (EUAs) for several products meant to combat COVID-19. These include the June 15, 2020 revocation [fda.gov] (download 1) of the...