Medmarc Blog (blog.medmarc.com)
Congress Pushes CMS to Reconsider MCIT Program
The Centers for Medicare & Medicaid Services has formally scuttled its proposal to cover breakthrough medical devices, but recent developments have breathed new hope into the Medicare Coverage...
FDA Guidance Addresses Definition of Counterfeit Devices
The FDA has published a draft guidance that explains the agency’s authority to destroy counterfeit devices, an authority the agency did not enjoy until passage of the Safeguarding Therapeutics...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
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.
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’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FDA Posts De Novo Final Rule, Electronic Submissions Draft Guidance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center resumed work recently on its regulatory to-do list with a final rule for applications for de novo devices and a draft guidance for electronic submissions.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...