Medmarc Blog (blog.medmarc.com)
FDA (11)
Are You in Compliance with FDA Post-approval Study Requirements?
On May 27, 2021, the FDA issued two draft guidances for studies of devices after approval or clearance. The draft guidances would impose much shorter timelines for both post-approval studies and...
Listing All Constituent Materials in Your Medical Device: The Future of Medical Device Labeling
On May 20, 2021, the FDA’s Center for Radiological Health (CDRH) issued a paper discussing labeling long-term medical devices to include all materials that will come in contact with human...
Are You Remanufacturing or Servicing the Product?
On June 17, 2021, the FDA issued a draft guidance for remanufacturing medical devices. With this guidance, the FDA aims to distinguish between remanufacturing and servicing and to instruct the...
Two Paths Open for Medicare Coverage of Breakthrough Devices
The Centers for Medicare & Medicaid Services has suspended the Medicare Coverage of Innovative Technology (MCIT) program through at least the end of the year, and possibly permanently. However,...
Controversies over Diagnostics Renewed
Controversies over Diagnostics Renewed The diagnostic test played a vitally important role during the COVID-19 pandemic, but controversy has followed in vitro diagnostics nonetheless. The...
FDA Guidance for Medical Devices in MRI Facilities/Magnetic Resonance Environments - and What It Means for Products Liability
The FDA has issued final guidance for testing and labeling medical devices for safety in the magnetic resonance environment. This guidance will be essential for manufacturers of both implantable...
FDA Eyes Remote Inspections After COVID
The FDA has provided an overview of the impact of the COVID-19 on its inspectional regime for drugs, devices and biologics, which seriously impeded inspections of all but top priority...
FDA Device Notification Rule Withdrawn
The FDA has withdrawn a Jan. 15, 2021, rule by the Department of Health and Human Services that had would have exempted more than 80 medium-risk device types from premarket notification...
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...