Medmarc Blog (blog.medmarc.com)
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...
ONC, CMS Delay Compliance Dates for EHR Interoperability
The COVID-19 pandemic has incurred a number of regulatory casualties in recent weeks, and the final rules for electronic health records (EHRs) promulgated earlier this year are two of the...
EMA Proposes Delay of MDR Implementation
As the world grapples with the newest version of the coronavirus, regulatory agencies across the globe are reacting with a number of moves, mostly to relax existing regulatory requirements. In...
An Overview of Liability Immunity for Products Meant to Counter COVID-19 Under the PREP Act
Device manufacturers (as well as drug manufacturers, distributors, and health care providers) are struggling to answer many questions regarding their potential products liability in responding...
Pandemics and Force-Majeure Clauses
With the Coronavirus (COVID-19) pandemic, medical device companies are facing disruptions to their supply chains, vendors who simply stop providing services, and a denuded work force. Who is...
FY 2021 Budget Proposal Hits NIH, Mostly Flat for FDA
The Trump administration’s budget proposal for fiscal 2021 in large part reflected the administration’s past proposals for various agencies at the Department of Health and Human Services. While...