Medmarc Blog (blog.medmarc.com)
FDA’s Device Center Issues Two Guidances for Appeals
The FDA has released two guidances for appeals of regulatory decisions, one each for mammography facilities and the other for medical device premarket reviews. These are the first two final guidances...
Preparedness Emphasized in FDA Voluntary Recall Guidance
The FDA final guidance for voluntary recalls applies to all FDA product centers, devices and drugs included, and offers some clarity regarding terminology. However, the agency urged companies to take...
Major Regulatory Changes May Be Underway in U.K.
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed to overhaul its regulatory framework for medical devices that will span all medical technologies. The...
FDA, Health Canada, MHRA Release AI/ML Medical Device Guiding Principles
The U.S. Food and Drug Administration (FDA) has come together with other international Public Health counterparts to outline a set often guiding principles related to medical devices that use...
FDA Posts De Novo Final Rule, Electronic Submissions Draft Guidance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center resumed work recently on its regulatory to-do list with a final rule for applications for de novo devices and a draft guidance for electronic submissions.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The Centers for Medicare & Medicaid Services has fully withdrawn the rule for Medicare Coverage of Innovative Technology (MCIT), which eliminates any prospect for automatic coverage of...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,...