Medmarc Blog (blog.medmarc.com)
The United Kingdom’s MHRA Moved towards a New Regulatory Framework for Medical Devices
Brexit has given regulatory bodies in the United Kingdom (UK), such as the Medicines and Healthcare products Regulatory Agency (MHRA), great freedom. They are using that freedom to pave the way...
FDA’s Continued Efforts to Mitigate Drug Shortages is Facilitated by the Launch of the New NextGen Portal
The CARES Act, signed into law on March 27, 2021, is aimed at managing the COVID-19 crisis and moderating its economic impact. Section 3112 of the CARES Act enabled FDA to avoid drug shortages...
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’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...
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....
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On June 17, 2021, the FDA issued a draft guidance for remanufacturing medical devices.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...
Is My Product a Drug or a Device? The D.C. Circuit Court Weighs in on this Question
There are several important differences between FDA regulations of pharmaceuticals and medical devices. These differences span from regulation of promotion and advertising to the testing...
Products Liability Lessons from the Ninth Circuit’s Ruling on Dan Abrams Co. v. Medtronic Inc.
The United States Court of Appeals for the Ninth Circuit has set forth a key ruling in Dan Abrams Co. v. Medtronic Inc.; reasserting an important precedent for off-label use and creating a...