21 U.S.C. § 360h — Notification and other remedies

(a) Notification. If the FDA finds that a marketed device presents an unreasonable risk of substantial harm to public health, and that notifying people is necessary to eliminate that risk — with no more practical way to fix it under other parts of this law — the FDA can order adequate notice be given to health professionals who prescribe or use the device, and to anyone else (manufacturers, importers, distributors, retailers, or users) who should reasonably get it. The order must include the affected patients themselves, unless the FDA decides that telling them directly would be more dangerous than not telling them; in that case, the order requires health professionals to notify their own patients instead, along with what those patients can do about the risk. Before issuing this order, the FDA must consult with the people who will have to give the notice. (b) Repair, replacement, or refund. (1)(A) After giving an informal hearing, if the FDA determines that a device presents an unreasonable risk of substantial harm, that there are reasonable grounds to believe it was poorly designed or made for its time, that the risk wasn't caused by someone else's careless installation, maintenance, repair, or use, and that notification alone won't fix the problem, the FDA can order the manufacturer, importer, or any distributor (or several of them together) to submit a plan for repairing, replacing, or refunding the device. If the order goes to more than one person, it must say who decides the plan's details — normally whoever bears the main financial responsibility, unless the FDA can't tell who that is or decides the public health requires someone else (even a user or health professional) to decide. (B) The FDA must approve a submitted plan unless, after another informal hearing, it decides the plan won't actually fix the risk. If the FDA rejects a plan, it orders a revised one. If that revised plan is also unsatisfactory, or no plan is submitted in time, the FDA either writes its own plan for the original recipients to follow, or — after another informal hearing — orders a different manufacturer, importer, distributor, or retailer to carry out a plan. (2) The plan can require: (A) repairing the device so it no longer poses the risk; (B) replacing it with an equivalent device that meets all legal requirements; or (C) refunding the purchase price, minus a reasonable deduction for use if the device owner has had it for a year or more. (3) Ordinary users (not manufacturers, importers, distributors, or retailers) pay nothing to use these remedies, and the person under the order must reimburse them for reasonable, foreseeable costs of getting the remedy. (c) Reimbursement. If the FDA decides it's needed to protect public health, an order under subsection (b) can require one manufacturer, importer, distributor, or retailer to reimburse another for their actual costs of carrying out the order. This doesn't change any rights or duties either side has under their own contracts. (d) Effect on other liability. Following an order under this section doesn't excuse anyone from liability under other federal or state law. But if a lawsuit over that liability seeks money for economic loss, the court must credit the value of any remedy the person already got under the order. (e) Recall authority. (1) If the FDA finds a reasonable probability that a device would cause serious harm or death, it must order the relevant people (manufacturers, importers, distributors, or retailers) to immediately stop distributing the device, and to immediately tell health professionals and facilities to stop using it. The order must offer an informal hearing within 10 days, covering whether the required actions are right and whether the order should be expanded into a full recall. If, after that hearing, the FDA decides the order wasn't justified, it must cancel the order. (2)(A) If, after that hearing, the FDA decides the order should include a recall, it must — with the exceptions below — amend the order to require one, set a timetable for the recall, and require regular progress reports. (B) That amended recall order cannot require recalling the device from individual patients, and cannot require recalling it from device-user facilities if the FDA decides that recalling it would be riskier than leaving it in place. It must still require notice to affected individual patients — the FDA can use health professionals to help deliver that notice, and if too many patients can't be identified, the FDA notifies them under section 375(b) instead. (3) These recall remedies are in addition to, not instead of, the remedies under subsections (a), (b), and (c).