Medical Devices; Temporary Suspension of Approval of a Premarket Approval Application

The Food and Drug Administration (FDA) is establishing procedures to order the temporary suspension of approval of a premarket approval application (PMA) for a medical device. This action is being taken under a new authority granted to the agency by the Safe Medical Devices Act of 1990 (the SMDA). Under this new authority, if, after providing an opportunity for an informal hearing, FDA determines there is a reasonable probability that continued distribution of a device would cause serious, adverse health consequences or death, the agency shall, by order, temporarily suspend approval of a PMA, and proceed expeditiously, but within 60 days, to permanently withdraw approval of the PMA. The final rule also clarifies that these procedures apply to an original PMA, as well as any PMA supplement(s), for a medical device. EFFECTIVE DATE: May 6, 1996. FOR FURTHER INFORMATION CONTACT: Lisa A. Rooney, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4765, ext. 164. SUPPLEMENTARY INFORMATION: