Medtech Insight is part of the Business Intelligence Division 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

Expect more Class I recalls, inspections, analysts say

This article was originally published in The Silver Sheet

Executive Summary

Device industry analysts say the FDA regulatory environment will become more challenging before eventually stabilizing, resulting in more Class I recalls and tougher manufacturing inspections. "Wholesale reform" of device regulation has been accelerated by the new FDA administration and CDRH Director Jeffrey Shuren, Morgan Stanley device analysts noted in a July 12 report. The analysts predict that device recalls will become more frequent and are more likely to be classified as Class I. "Class I recalls used to be fairly uncommon and pretty visible," Jeff Gibbs, an attorney with the Washington, D.C., law firm Hyman, Phelps &McNamara, said in a July 9 conference call hosted by Morgan Stanley. He questioned whether up-classifying recalls benefited public health, because "removing products from the market can be accomplished very effectively with a Class II recall." Further, the analysts noted that they expect to see more FDA-483 forms, listing possible violations, given to firms following an inspection
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT036508

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