Medmarc Blog (blog.medmarc.com)
The MDCG’s New Guidance on Classification of Medical Devices
In October 2021, the Medical Device Coordination Group (MDCG) published a guidance to aid medical device manufacturers in complying with classification rules in the European Medical Device...
FDA Released New List of AI/ML-Enabled Medical Devices
In September 2021, FDA’s Digital Health Center of Excellence released a list of artificial intelligence/machine learning-based software as a medical device (“AI/ML-based SaMD”) that are marketed
FDA Posts De Novo Final Rule, Electronic Submissions Draft Guidance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center resumed work recently on its regulatory to-do list with a final rule for applications for de novo devices and a draft guidance for electronic submissions.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...
FDA’s Final Guidance on Unique Device Identifier
On July 7, 2021, FDA released their final guidance document regarding the content and forms of Unique Device Identifiers (UDIs). The recommendations are written specifically for labelers of...
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The Centers for Medicare & Medicaid Services has fully withdrawn the rule for Medicare Coverage of Innovative Technology (MCIT), which eliminates any prospect for automatic coverage of...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...
Large Entity or Small Entity: A Confusion in the Distinction Could Cause You to Lose Your Patent
Anyone who has obtained a patent can attest that it is an expensive endeavor. The United States Patent and Trademark Office (USPTO) requires a fee for nearly every step taken by the applicant....
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On June 17, 2021, the FDA issued a draft guidance for remanufacturing medical devices.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...