Medmarc Blog (blog.medmarc.com)
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On June 17, 2021, the FDA issued a draft guidance for remanufacturing medical devices.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...
FTC Moves Aggressively on Rulemaking and Mergers
The U.S. Federal Trade Commission has undertaken several decisive moves since the beginning of the year, including the formation in March of a multi-lateral work group for mergers in the...
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...
Two Paths Open for Medicare Coverage of Breakthrough Devices
The Centers for Medicare & Medicaid Services has suspended the Medicare Coverage of Innovative Technology (MCIT) program through at least the end of the year, and possibly permanently. However,...
Controversies over Diagnostics Renewed
Controversies over Diagnostics Renewed The diagnostic test played a vitally important role during the COVID-19 pandemic, but controversy has followed in vitro diagnostics nonetheless. The...
FDA Guidance for Medical Devices in MRI Facilities/Magnetic Resonance Environments - and What It Means for Products Liability
The FDA has issued final guidance for testing and labeling medical devices for safety in the magnetic resonance environment. This guidance will be essential for manufacturers of both implantable...
CMS Adds Administrator, Hits Pause on MCIT
CMS Adds Administrator, Hits Pause on MCIT The Center for Medicare & Medicaid Services has a new administrator, Chiquita Brooks-LaSure, signaling an end to a leadership void at an agency that is...
FDA Eyes Remote Inspections After COVID
The FDA has provided an overview of the impact of the COVID-19 on its inspectional regime for drugs, devices and biologics, which seriously impeded inspections of all but top priority...