Medmarc Blog (blog.medmarc.com)
Off Label Promotion
CMS Announces Full Withdrawal of MCIT Rule
The Centers for Medicare & Medicaid Services has fully withdrawn the rule for Medicare Coverage of Innovative Technology (MCIT), which eliminates any prospect for automatic coverage of...
Device Makers Beware: Device Design a Hazard in New FDA Intended Use Rule
Device makers should be aware of the new FDA intended use rule, which concludes an overhaul of the previous version that was six years in the making. One of the key differences between the new...
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...
FDA Revisits Intended Use Rule | Medmarc
The FDA’s policy for determining a manufacturer’s intended use has strained relations between the agency and industry in the past, but the agency said in a press release that the latest version...