On September 24, 2013, FDA issued regulations establishing a unique device identification system for medical devices along with implementation timeframes for certain medical devices (78 FR 58786) (the UDI Rule). FDA established a set of compliance dates, by device classification, for compliance with required labeling and data submission to the Global Unique Device Identification Database (GUDID) under the UDI Rule. For class III devices and devices licensed under the Public Health Service Act, the compliance date was September 24, 2014. FDA granted requests for extensions to the compliance date some of which expire on September 24, 2015. For implantable, life sustaining and life supporting devices (other than class III devices which had a compliance date of September 24, 2014), the compliance date is September 24, 2015.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.