Mandated Postapproval Studies

It has become increasingly common for the FDA to require sponsors of Class III devices to conduct postapproval clinical studies as a mandatory condition of PMA approval. These studies are usually narrow in scope and focus on generating additional data to expand on results of pivotal trials in support of product approval. The objective is typically longer-term follow-up. The trend toward mandated postmarket surveillance is positive in that it represents an agency shift toward allowing a device to enter into the marketplace with certain postmarket constraints in place rather than postponing approval until further data is generated. For example, the FDA-approved Johnson & Johnson/ Independence Technology's iBOTâ„¢ stair-climbing wheelchair with the condition that the company file reports "summarizing usage information obtained from data logs, reported device failures, and reported adverse events" for the first 2 years of the iBOT's postmarket use.50 The FDA further required that physicians and other health professionals undergo special training to prescribe the iBOT.

To date, the FDA has not issued formal regulations regarding its mandatory postmarket surveillance policy, but the agency has developed several nonbind-ing guidance documents. Within the broad category of devices for which postmarket surveillance may be required, the FDA has identified internal criteria to determine when to order surveillance.57 The principal criterion is whether there are important unanswered questions about marketed devices.

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