Medmarc Blog (blog.medmarc.com)
FDA (5)
FDA Guidance Promises Closer Scrutiny of Medical Device Cybersecurity
The FDA’s most recent final guidance for medical device cybersecurity represents a significant shift in the agency’s perspectives regarding cybersecurity, which is part of a broader emphasis on...
FTC Seeks to Remove Medical Patents from FDA’s Orange Book
The Federal Trade Commission has challenged more than 100 medical patents the agency believes are improperly listed in the FDA Orange Book, a compendium of drug products the FDA has deemed safe and...
FDA Releases New Draft Guidance for Unapproved Uses
The FDA has released a new draft guidance for communications with health care providers (HCPs) regarding unapproved uses of drugs and devices that are commercially available. This is a reissue of a...
A Guide to FDA's Labeling Guidelines on Biosimilars and the Implications for Products Liability
The field of biopharmaceuticals has witnessed significant advancements in recent years, particularly in the realm of biosimilars. Biosimilars are biological products that are similar to an...
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New FDA Draft Guidance Offers Clarity for 510(k) Requirements
The FDA has released a new draft guidance which explains when clinical data may be needed for 510(k) submissions, an essential explanation of the agency’s policy for the 510(k) program.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...
FDA Releases Draft Guidance for Implanted 510(k) Devices
In September 2023, the FDA published several new draft guidance documents for Class II, moderate-risk devices as part of the agency’s agenda to modernize the 510(k) program.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...
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...