Medmarc Blog (blog.medmarc.com)
FDA Releases Draft Guidance for Implanted 510(k) Devices
In September 2023, the FDA published several new draft guidance documents for Class II, moderate-risk devices as part of the agency’s agenda to modernize the 510(k) program.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...
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...
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...
FDA Encountering Strong Opposition to CDS Final Guidance
The FDA guidance for clinical decision support (CDS) programs was intended to provide clarity for this important category of device products, but the guidance has run into unexpected headwinds....
Merger Reviews in U.S. to be More Closely Scrutinized
The U.S. federal government is considering a more careful review of mergers and acquisitions per a proposal announced recently by the U.S. Department of Justice (DoJ) and the Federal Trade...
FDA Guidance: Rulemaking for Patient Medication Information
The FDA has issued a final guidance for the presentation of quantitative efficacy and risk information for pharmaceutical direct-to-consumer (DTC) advertising, but this is only one of two recent...
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...
FTC Seeks to Expand Scope of Breach Notification Rule
The Federal Trade Commission has issued a proposal to update the Health Breach Notification Rule (HBNR) that expands the sweep of the rule to functions and products not previously within the...
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...