NJ A2015

Manufacturers of recalled medical devices must provide consumers with a free replacement device, or if unavailable from the manufacturer, purchase a comparable replacement from another manufacturer.

Manufacturers must comply with replacement requirements within 30 days of the recall being issued.

The bill applies when recalls require consumers to stop using or return a medical device to the manufacturer.

Violations constitute unlawful practices under New Jersey's consumer fraud act, carrying penalties up to $10,000 for first offenses and $20,000 for subsequent offenses, plus potential cease and desist orders, punitive damages, and treble damages.

"Medical device" follows the federal definition under the Federal Food, Drug and Cosmetic Act (21 U.S.C. s.321).