Medmarc Blog (blog.medmarc.com)
Evolving Labels and Warnings for AI-Enabled Devices: Managing Risks
When FDA finalized its guidance on Predetermined Change Control Plans (PCCPs) and, shortly after, joined Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in...
FDA Guidance on AI Medical Devices: Predetermined Change Control Plans
One of the challenges regulators face with AI-enabled medical devices is that they are not static products. Unlike a traditional implant or diagnostic tool, the device that receives FDA approval may...
Patients, Manufacturers Plead for Medicare Breakthrough Device Coverage
A group of 67 patient groups and life science organizations has petitioned the Centers for Medicare & Medicaid Services for coverage of breakthrough medical devices. The request comes at a time when...
AdvaMed Celebrating 50 Years
AdvaMed, the MedTech Association, is celebrating its 50th anniversary in 2025. For five decades, AdvaMed has championed innovation, policy, and advocacy on behalf of the medical technology...
12 Essential Things - Product Liability Insurance Coverage
Here are 12 essential things that life sciences clients should have included with their product liability insurance coverage, based exclusively on insights from Medmarc: Tailored Coverage for...
FDA, Device Makers in Negotiations For Next User Fee Agreement
The FDA and the medical device industry are officially in negotiations for the sixth medical device user fee agreement (MDUFA VI), negotiations which are taking place as fees under the current...
H.R. 1 Restores Deductibility of Research and Development Expenses
Both chambers of the U.S. Congress have passed House Resolution 1 (H.R. 1), which offers several significant tax benefits for companies in the life sciences industry. One of the most important of...
FDA Unveils Voucher Program for High Priority Therapeutic Products
The FDA has established a new priority review program for premarket applications for pharmaceuticals that reflects the agency’s health priorities. Under this program, the premarket review process...
AdvaMed Supportive of Three Bills for the MedTech Industry
Three bills have been introduced to Congress that may improve the prospects for manufacturers of medical devices, two of which would improve the outlook for the entire industry. The Advanced Medical...
AdvaMed Presses Senate on Urgency of Tariff Relief for Medical Devices
Tariffs placed on medical devices could impede patient access to these lifesaving products, an argument made by Scott Whitaker, President and CEO of the Advanced Medical Technology Association...