Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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).
UsernamePublicRestriction

Register

MT003455

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel