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Medmarc Blog (blog.medmarc.com)

FDA Guidance Addresses Definition of Counterfeit Devices

December 21, 2021

The FDA has published a draft guidance that explains the agency’s authority to destroy counterfeit devices, an authority the agency did not enjoy until passage of the Safeguarding Therapeutics...

The United Kingdom’s MHRA Moved towards a New Regulatory Framework for Medical Devices

December 15, 2021

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...

Major Regulatory Changes May Be Underway in U.K.

December 08, 2021

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

November 19, 2021

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’s Continued Efforts to Mitigate Drug Shortages is Facilitated by the Launch of the New NextGen Portal

November 17, 2021

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

October 21, 2021

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

October 15, 2021

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FDA Posts De Novo Final Rule, Electronic Submissions Draft Guidance

October 14, 2021

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center resumed work recently on its regulatory to-do list with a final rule for applications for de novo devices and a draft guidance for electronic submissions.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

October 05, 2021

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

September 22, 2021

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...