Medmarc Blog (blog.medmarc.com)
FDA Proposes End to Enforcement Discretion for Lab-Developed Tests
The FDA has released a draft rule for regulation of lab-developed tests (LDTs) that would terminate the existing policy of enforcement discretion over a period of approximately four years. The...
New FDA Draft Guidance Offers Clarity for 510(k) Requirements
The FDA has released a new draft guidance which explains when clinical data may be needed for 510(k) submissions, an essential explanation of the agency’s policy for the 510(k) program. When...
AdvaMed and CapView Propose Plan for Medicare Coverage of AI
The Advanced Medical Technology Association (AdvaMed) and CapView Strategies have collaborated to produce a series of recommendations for improving Medicare coverage of artificial intelligence (AI),...
FDA Releases Draft Guidance for Implanted 510(k) Devices
In September 2023, the FDA published several new draft guidance documents for Class II, moderate-risk devices as part of the agency’s agenda to modernize the 510(k) program.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...
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...