FDA: Manufacturers Failing to Comply with Postmarket Conditions of Approval

Seeking to protect the public health without hindering the movement of innovative technologies into the marketplace, FDA has long struggled to find the elusive balance between premarket and postmarket review of medical devices. In recent years, the agency has increasingly required the manufacturers of Class III medical devices to establish patient registries and reporting mechanisms or to undertake significant postmarket studies as a condition of approval (COA) for their premarket approval (PMA) applications.

Such requirements can be imposed even when companies have already conducted extensive clinical trials prior to submitting their product for approval. Earlier this month, for instance, FDA's general and plastic surgery panel recommended that a PMA be granted for the silicone breast implant by Mentor Corp. (Santa Barbara, CA), but also suggested that the agency impose a number of conditions for postmarket monitoring. It remains to be seen how the agency will respond to the panel's recommendations.

According to a recent FDA report, however, all of the agency's hand-wringing over postmarket requirements may be for naught. Issued by FDA's device center at the end of March, Center for Devices and Radiological Health Condition of Approval Studies as a Postmarket Tool for PMA Approved Cohort 1998–2000, reveals that medtech manufacturers have a dismal record of compliance with conditions imposed by FDA when approving PMA devices.