In the shadow of the FDA’s new Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device, manufacturers are left to contemplate enhanced product liability exposure. AI-powered devices ingest new data and adjust accordingly – a feature that…
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How Smart is it for Medical Devices to Learn New Tricks? The FDA Seeks Feedback On Its Proposed Regulatory Framework for Artificial Intelligence/Machine Learning-Based Medical Devices
Posted in FDA
ALERT: U.S. Supreme Court Grants Certiori to Decide Whether FDA Excluded Warnings Pre-Empt State Law Claims
The U.S. Supreme Court today agreed to consider a Third Circuit ruling that revived litigation over Merck’s alleged failure to warn about a risk of femoral fractures from its osteoporosis drug Fosamax. The precise question presented on appeal is “whether…
FDA releases draft guidance on expansion of abbreviated 510(k) Program
On April 12, the FDA released draft guidance discussing an expansion of its Abbreviated 510(k) program for medical devices. This new guidance would allow a submitter to establish substantial equivalence by demonstrating that a new medical device meets certain performance…
The Legality of Cannabidiol and Concerns Regarding False Advertising
The legality of marijuana (also known as cannabis) has been a popular topic in recent years with thirty states and the District of Columbia having laws that legalize marijuana in some form. However, under federal law, marijuana is a Schedule…
Proposed Legislation to Relax Rules on Medical Device Reporting Passes U.S. House
On July 13, 2017, the U.S. House of Representatives passed a bill that would triple the amount of time in which medical device manufacturers are required to report certain malfunctions of some products to the Food and Drug Administration. Companies…
Lack of Specificity May Kill Parallel State Law Product Claims, But Not Fraud Claim
A Michigan district court judge determined last week that product liability claims against an FDA approved medical device manufacturer were preempted by federal law, but allowed the plaintiff’s claim of fraud against the manufacturer, Medtronic, Inc., to proceed at the…
Words Matter: Product Claims Can Trigger Regulatory Application And Corrective Action
Most of us understand that the facts that give rise to the legal issues we face are sometimes sewn far in advance. This is certainly true in the area of product claims or statements. As is discussed below, careful consideration…
Tagged with: essential oils, FDA warnings, FDCA, labeling, natural ingredients, organic products
Posted in FDA
Posted in FDA
The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims
The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law.[1] Under the Federal Food, Drug,…
Posted in FDA
FDA Issues New Draft Guidance Requiring Modifications to Medical Device Tracking Labels
The Food and Drug Administration released draft guidance last week revealing its intent to better track medical devices, from pacemakers to condoms, through an amendment to its 2013 “UDI (unique device identifier) Rule”. The draft guidance is intended to assist…
Posted in FDA
New FDA Draft Guidance on Updates to Certain Generic Labeling
On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for reasons other than safety or…
Posted in FDA
