DEVICE CIVIL PENALTIES CAN BE IMPOSED WITHOUT ISSUANCE OF FINAL RULE, FDA SAYS IN RESPONSE TO LAWSUIT; AGENCY HAS "NO PLANS" TO PUBLISH PMS REG
This article was originally published in The Gray Sheet
Executive Summary
Existing FDA procedures for device civil penalties allow FDA to enforce the provision of the Safe Medical Devices Act of 1990 without publishing a final rule, the agency argues in response to a lawsuit brought by Public Citizen. In the Oct. 28, 1994 complaint, Public Citizen argued that FDA's failure to finalize civil penalty rules and three other regulations constitutes an "unreasonable delay" under the Administrative Procedures Act and asked the court to order the agency to publish the regs ("The Gray Sheet" Oct. 31, 1994, p. 18).