Advertising & Marketing


What You Can and Can’t Say in Advertising Devices

It can be a bit tricky for medical device makers to make sure their advertising materials are following the letter of the law in the eyes of the FDA. Read More

Claims for Dynavision D2 Exceeded Approved Indications, FDA Says

An Ohio company violated federal regulations for medical devices by making claims for its product that were not approved by the FDA, the agency said in a warning letter. Read More

Biocompatibles Inc. Pleads Guilty to Misbranding Embolic Device

Biocompatibles Inc. has pleaded guilty to misbranding its embolic device called LC Bead and will pay more than $36 million in criminal and civil fines, the Justice Department announced. Read More

Ethics Code Could Limit Training on Devices in India

A new requirement that devicemakers follow India’s guidelines on marketing medical products could make it harder for companies to provide training on new equipment, an expert says. Read More

Medtronic to Pay $2.8M for SubQ False Claims

Irish medical device giant Medtronic will pay the U.S. government $2.8 million to resolve False Claims Act allegations related to subcutaneous chronic pain treatments. Read More

FTC Raps Software Firm for Making Unproven Health Benefit Claims

While recent U.S. FDA guidance widens the range of wellness products that can be sold without agency approval, that doesn’t mean companies making dubious claims will escape federal intervention — as one software company recently found out. Read More

Turkey Bans Ads on Some Medical Devices, Requires ‘Qualified’ Employees for Sales

Industry is raising concerns about a new Turkish regulation that bans advertisements of certain medical devices and requires device sales centers to be government-certified and employ “qualified” persons. Read More

China Clamps Down on False Ads, 18 Companies Caught Up in Sting

The China Food and Drug Administration has ordered 18 devicemakers to stop publishing advertisements that make false claims about the effectiveness of their products — a move some say shows a new willingness to crack down on illegal ads. Read More

FDA: Manufacturers Have Choice on Fixing False Statements Online

Medtech companies are under no obligation to correct misleading third-party statements or claims about their products made on social media, websites and online forums — even if the website is owned by the manufacturer. Read More

Companies Should Track All Marketing to Build Defense Against Future Suits

A rise in whistleblower lawsuits involving off-label marketing of medical devices has sparked increased scrutiny by the FDA, and the suits are not likely to stop anytime soon, experts say. Read More