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

Corrections and removals reg's 10-day reporting deadline triggered by firms' internal meetings -- FDA.

This article was originally published in The Gray Sheet

Executive Summary

CORRECTIONS AND REMOVALS REG 10-DAY REPORTING DEADLINE TRIGGERED by a firm's internal decision on a recall, Casper Uldricks, Special Assistant to the Director of Compliance in FDA's Center for Devices and Radiological Health, explained at the Oct. 21 Association of Medical Diagnostics Manufacturers annual meeting in Rockville, Maryland. Noting that FDA's corrections and removals regulation is "very clear" that a firm must report within 10 working days when it initiates a Class I or Class II recall, the FDAer explained that "`Initiates' means that moment in time when a firm makes the first contact within or outside the firm that begins the corrective or removal action."
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT009006

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