Medmarc Blog (blog.medmarc.com)
FDA Posts De Novo Final Rule, Electronic Submissions Draft Guidance
The FDA’s device center resumed work recently on its regulatory to-do list with a final rule for applications for de novo devices and a draft guidance for electronic submissions. While the...
CMS Announces Full Withdrawal of MCIT Rule
The Centers for Medicare & Medicaid Services has fully withdrawn the rule for Medicare Coverage of Innovative Technology (MCIT), which eliminates any prospect for automatic coverage of...
Device Makers Beware: Device Design a Hazard in New FDA Intended Use Rule
Device makers should be aware of the new FDA intended use rule, which concludes an overhaul of the previous version that was six years in the making. One of the key differences between the new...
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...
FTC Moves Aggressively on Rulemaking and Mergers
The U.S. Federal Trade Commission has undertaken several decisive moves since the beginning of the year, including the formation in March of a multi-lateral work group for mergers in 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...
CMS Adds Administrator, Hits Pause on MCIT
CMS Adds Administrator, Hits Pause on MCIT The Center for Medicare & Medicaid Services has a new administrator, Chiquita Brooks-LaSure, signaling an end to a leadership void at an agency that is...
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...
Supreme Court Delivers Unanimous Repudiation to FTC
The U.S. Supreme Court has ruled in a case involving the Federal Trade Commission regarding limits to the agency’s statutory authority to obtain restitution from defendants in a range of...