New FDA UDI Requirements to be Phased In over Seven Years
A final rule from US regulators on Unique Device Identifier (UDI) requirements will begin taking effect by late 2013 in an effort to reduce errors caused by misidentification of medical devices.
The Food and Drug Administration’s UDI rule will impose the following new requirements on most medical device manufacturers registered in the US:
- Submission of device information to a new Global Unique Device Identification Database (GUDID)
- Inclusion of a UDI on device labeling and packaging
- Provision of a UDI in both plain-text and automatic identification and data capture (AIDC) formats
- Inclusion of UDI information directly on devices intended for multiple uses and requiring reprocessing after each use
As expected based on draft FDA rules, each UDI must include two components: a device identifier pertaining to a device’s specific model and labeler; and a production identifier that provides lot or batch, serial number, expiration date and date of manufacture data. Manufacturers must obtain UDIs for their devices only from FDA-accredited issuing agencies.
UDI compliance phase-in
Manufacturers will have up to seven years to come into full compliance with the new UDI rule depending on the risk profiles and classifications of their products. Manufacturers of high-risk devices will have to ensure UDI compliance within one or two years, while lower-risk device makers will have more time. Full compliance among all manufacturers is expected by September 2020.
Wait-and-see industry reaction
US medical device industry trade group AdvaMed reacted with highly cautious optimism to the FDA UDI rule’s publication, calling it a “good step” toward developing an effective UDI system not unduly burdensome for manufacturers. That sentiment may change, of course, once implementation begins and companies get a better idea of compliance costs.