Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Device Firms Get Extra Time To Remove Drug Codes From Product Labels

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration will allow some medical device packaging to continue to carry national drug code (NDC) or national health related item code (NHRIC) numbers until 2021, despite a regulation stating the codes need to be removed before then. The policy, laid out in a draft guidance released Feb. 2, will apply to certain devices manufactured and packaged before Sept. 24, 20181.

You may also be interested in...



FDA Guidance: Industry May Use Legacy Codes Until 2021

A final guidance document issued Aug. 30 will allow manufacturers to keep using legacy codes, such as National Health Related Item Codes and National Drug Code numbers, until Sept. 24, 2021. The agency previously indicated all legacy codes should be removed from device packaging by Sept. 24, 2018, at the latest.

EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions

It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.

How Ochre Bio Bagged Boehringer For Its RNA-Based Regenerative MASH Therapies

UK-based Ochre Bio has signed its first major deal with Boehringer Ingelheim. Scrip talked to its co-founder and CEO, Jack O’Meara, about its human tissue-based drug discovery platform, its resulting RNA platform for liver disease and how the fledgling drug company's early work mirrored that seen in diagnostics.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT040711

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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