Medmarc Blog (blog.medmarc.com)
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After a wait of two years, the FDA has concluded the draft guidance for multiple function devices with a final version that makes several substantive changes.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...
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...
Churn at Justice as Drug Pricing Rule Falters Again
Bipartisan supporters of drug pricing transparency in the U.S. absorbed another blow when an appeals court rejected the Trump administration’s drug price transparency rule as lacking statutory...
FDA Moves on Home Sample Collection for COVID-19
The FDA has broken new ground on numerous occasions as a result of the COVID-19 pandemic, including with the release of a voluntary template for at-home sample collection kits under the emergency...
FDA Issues Pandemic Policy for Supplements
The FDA and other agencies at the U.S. Dept. of Health and Human Services have taken a number of measures to push back against the COVID-19 pandemic, but an agency at the Dept. of Commerce is...
PTO Eyes Prioritized Patents to Combat Covid-19
The FDA and other agencies at the U.S. Dept. of Health and Human Services have taken a number of measures to push back against the COVID-19 pandemic, but an agency at the Dept. of Commerce is...