§360h Notification and Other Remedies

Summary

The head of the FDA can order people to warn others if a medical device on the market creates an unreasonable risk of serious harm to the public and no easier way exists to stop the danger. The FDA can require that warnings go to doctors, hospitals, manufacturers, importers, distributors, retailers, device users, and patients. The FDA must include patients unless telling them would be more dangerous; if so, it can require doctors who used the device to warn their patients. The FDA will talk with those who must give the notice before ordering it. If the device is dangerous, likely badly designed or made, and the harm was not caused by misuse, and warning alone is not enough, the FDA can make manufacturers, importers, or distributors submit a plan to fix the problem after a chance for an informal hearing. The plan can call for repair, replacement with a safe device, or a refund (minus a fair use allowance if the user had the device one year or more at the time of notice or actual knowledge, whichever comes first). Users must not be charged for these fixes and must be paid back for reasonable expenses. The FDA can make companies reimburse each other if needed to protect health. Following an FDA order does not remove other legal liability, and any fix given to a person counts when damages are decided. If there is a reasonable probability the device could cause serious injury or death, the FDA can order immediate stop of distribution and immediate notice to health professionals and facilities, hold an informal hearing no later than 10 days after the order, and require a recall with a timetable and progress reports if a recall is needed. The recall normally will not force removal from patients or from facilities when removal is more dangerous, and the FDA must make sure affected people are notified.