Medmarc Blog (blog.medmarc.com)
Products Liability
Evolving Labels and Warnings for AI-Enabled Devices: Managing Risks
When FDA finalized its guidance on Predetermined Change Control Plans (PCCPs) and, shortly after, joined Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in...
FDA Guidance on AI Medical Devices: Predetermined Change Control Plans
One of the challenges regulators face with AI-enabled medical devices is that they are not static products. Unlike a traditional implant or diagnostic tool, the device that receives FDA approval may...
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...
Listing All Constituent Materials in Your Medical Device: The Future of Medical Device Labeling
On May 20, 2021, the FDA’s Center for Radiological Health (CDRH) issued a paper discussing labeling long-term medical devices to include all materials that will come in contact with human...
Are You Remanufacturing or Servicing the Product?
On June 17, 2021, the FDA issued a draft guidance for remanufacturing medical devices. With this guidance, the FDA aims to distinguish between remanufacturing and servicing and to instruct the...
Is My Product a Drug or a Device? The D.C. Circuit Court Weighs in on this Question
There are several important differences between FDA regulations of pharmaceuticals and medical devices. These differences span from regulation of promotion and advertising to the testing...
Products Liability Lessons from the Ninth Circuit’s Ruling on Dan Abrams Co. v. Medtronic Inc.
The United States Court of Appeals for the Ninth Circuit has set forth a key ruling in Dan Abrams Co. v. Medtronic Inc.; reasserting an important precedent for off-label use and creating a...