Medmarc Blog (blog.medmarc.com)
Medical Device Manufacturers (2)
FDA’s Quality System Final Rule a Significant Revision
The FDA has published an updated version of its quality management requirements for medical devices, which is known as the Quality Management System Regulation (QMSR). This rule differs from the...
FDA Provides Greater Possibilities for Real-World Evidence
In 2023, the FDA prioritized the use of real-world evidence (RWE) for regulatory decision making for medical products, leading to the development of two guidance’s. In both cases, the FDA was...
FDA Releases Draft Guidance for Implanted 510(k) Devices
In September 2023, the FDA published several new draft guidance documents for Class II, moderate-risk devices as part of the agency’s agenda to modernize the 510(k) program. One of these is a draft...
FDA Informed Consent Guidance Subject to Near-Term Changes
On Aug. 15, 2023, the FDA released a guidance for informed consent which states that a medical device clinical trial may not proceed until the sponsor addresses the agency’s concerns regarding the...
Backlog of EU Device Applications Continues to Grow
The European Union’s ongoing struggles with the implementation of the Medical Device Regulation (MDR) are well known, although there are ways to make some of the associated workload more...
Medicare Rule for Breakthrough Devices Returns
The Centers for Medicare and Medicaid Services has resubmitted the rule for Medicare coverage of FDA breakthrough devices with a modified plan for the application and for the process of...
WHO Urges Nations to Adopt National Strategies for Diagnostics
In the wake of the COVID-19 pandemic, the World Health Organization has adopted a resolution that has received the backing of MedTech Europe and the Advanced Medical Technology Association...
FDA Seeks Feedback on AI in Drug Development, Manufacturing
The FDA is working to adapt its regulatory regimes to the use of artificial intelligence (AI) across the agency’s product centers, a response to the frequent use of AI for a variety of regulated...
FDA Draft Guidance For Predetermined Change Control Plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
Since the publication of the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan in 2021, interested parties have been awaiting guidance from...