Medmarc Blog (blog.medmarc.com)
FDA (2)
FDA’s Software Assurance Guidance Emphasizes Risk Management
The FDA’s guidance for computer software assurance (CSA) is not a groundbreaking policy document, but the guidance provides insight into how much effort a manufacturing site must put into verifying...
FDA’s QMSR Final Rule Now in Effect
The FDA’s Quality Management System Regulation (QMSR) is effective as of Feb. 2, 2026, two years after publication of the QMSR final rule. This new regulatory framework requires that manufacturers...
New 2026 FDA Wellness Guidance Provides Broader Exemptions
The FDA’s Jan. 6 guidance for general wellness products does not represent a wholesale overhaul of the previous version, but developers of these products may find that more of their products will...
FDA Overhauls Guidance for Clinical Decision Support
The FDA’s Center for Devices and Radiological Health has reissued its guidance for clinical decision support (CDS) software in a rewrite that significantly relaxes the regulatory qualifications for...
FDA’s Tightens Oversight of Cybersecurity in New Guidance
Recent security breaches at healthcare institutions have amplified the U.S. government’s concerns over cybersecurity, a fact reflected in the FDA’s most recent guidance on the subject. The June 2025...
FDA Product Centers Collaborate on AI Draft Guidance
The U.S. FDA posted a draft guidance for AI-enabled device software functions (DSFs) in January 2025, which provides much-needed clarity for a number of product types. All three of the agency’s...
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...
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...
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...