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


US FDA Now Assessing UDI Compliance When Inspecting Device Firms

This article was originally published in Clinica

Executive Summary

Unique device identification (UDI) activities are now being reviewed by US Food and Drug Administration investigators during medical device facility inspections, an agency official says. In addition, firms that aren't required yet to abide by the UDI regulation will be quizzed about their preparedness.

You may also be interested in...

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.

Keeping Track: US FDA Clears Esperion’s Nexletol, Baudax’ Anjeso, Agile’s Twirla

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Esperion’s Nexletol Reaches The Cholesterol Market Priced To Sell

Esperion obtained an on-time approval of Nexletol (bempedoic acid) for a pair of LDL cholesterol-lowering indications on 21 February. 





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