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

UDI Extensions: Convenience Kits, Repackaged Devices, Combo Products

Executive Summary

Just a little more than two weeks before the next Unique Device Identification compliance date, US FDA has granted two-year extensions to three product categories that raise particular complications for UDI labeling.

You may also be interested in...



Class I Device-Makers Get Wiggle Room As US FDA Pushes UDI Compliance Date To 2020

Manufacturers of low-risk class I products were given an extra two years to comply with FDA's Unique Device Identification requirements to give the agency and industry time to work through challenges posed by incorporating device identifiers into electronic health systems.

Manufacturers Scramble To Meet Looming Unique Device Identification Deadline – But Too Many Are Unprepared

US FDA and device industry experts are concerned that too many firms are woefully unprepared for, and undereducated about, the agency's Unique Device Identification program. A recent industry survey appears to bear this out: A whopping 85% of respondents say they're not ready for the upcoming UDI compliance deadline of Sept. 24 for makers of class II products. Meanwhile, firms asking for UDI exceptions for their devices are waiting an inordinate amount of time for FDA to come to a decision, in part because the agency simply doesn't know how to publicly disclose the exemptions, UDI guru Jay Crowley says. Also: experts mull over the agency's latest UDI guidance; FDA explains why using an HL7 UDI submission option for its GUDID database isn't a good idea for every firm; and Crowley discusses what the UDI landscape will look like in 2020.

FDA Proposes More Stringent UDI Requirements For Some Device 'Convenience Kits'

Under a draft guidance, more devices will require individual Unique Device Identification labels rather than being able to rely on a "convenience kit" exception in FDA's UDI regulation. The agency says surgical instruments packaged together for convenience but used and reprocessed for different procedures are too difficult to track without separately affixed or marked UDIs.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT103799

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