Scrip 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

FDA Surprised By Device Manufacturer's Quick Consent Decree Turnaround

This article was originally published in The Silver Sheet

Executive Summary

WHEN A DEVICE MANUFACTURER ENTERS INTO A CONSENT DECREE with FDA, it often takes years to solve its quality systems problems and obtain clearance to begin selling its devices again. However, Custom Ultrasonics, a Pennsylvania maker of endoscope disinfection systems, worked through its consent decree in less than four months. “It's the fastest I've seen around here,” CDRH Compliance Director Tim Ulatowski says. Ulatowski says FDA will consider making more use of consent decrees rather than issuing multiple warning letters to companies. Legal experts discuss how firms should handle a consent decre
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT036135

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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