Originally Published MX May/June 2005

BUSINESS NEWS

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 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. In April, 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.