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

FDA Won’t Immediately Dispatch Investigators, ‘Guns Blazing,’ To Enforce UDI Regulation

This article was originally published in The Gray Sheet

Executive Summary

The agency is likely to institute a period of enforcement discretion after impending unique device identification mandates take effect, but it won’t last forever, experts warn.

You may also be interested in...



FDA Releases Proposed Rule On UDI System, Ushering in ‘Modern Post-Market Surveillance System’

A proposed FDA regulation for a Unique Device Identification System is critical to the future of post-market safety surveillance, the agency says. The UDI system aims to reduce medical errors, and provide an array of other benefits for supply chain management. Makers of high-risk class III products will have one year to place UDI codes on devices. The UDI mandate will extend to moderate-risk class II devices two years later and to some low-risk class I devices two years after that.

Biogen Doubles Down On Alzheimer’s and Neuroscience With Sangamo Gene Regulation Deal

As sector awaits its aducanumab filing with bated breath, Biogen invests again in early stage neuroscience.

C-Suite Snippets: Growth Of A Cell And Gene Powerhouse

In case you missed it: catch up with snippets from interviews with industry leaders recently published by In Vivo.

Topics

UsernamePublicRestriction

Register

MT031670

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