MEMORANDUM 		DEPARTMENT OF HEALTH AND HUMAN SERVICES
                        PUBLIC HEALTH SERVICE
                        FOOD AND DRUG ADMINISTRATION
                        Center for Devices and Radiological Health


DATE:		December 2, 2013

FROM:  	Leslie M Tompkins 
		Informatics Staff
      Office of Surveillance and Biometrics (OSB)
      CDRH, White Oak Bld 66-3326

SUBJECT: 	Docket 92S-0251 - Transmittal

TO: 		Chief, Dockets Management Branch, HFA-305


Pursuant to 21 CFR Part 11.2(b) (2), and on behalf of the Center for Devices and Radiological Health (CDRH), please find attached notification of CDRH's readiness to accept electronic regulatory submissions for: 

Submission: 	Submission of Device Information (DI) record to the Global Unique Device Identification Database (GUDID), in compliance with the Unique Device Identification Rule
Regulatory Citation: 	21 CFR 830  
Effective Date: 	December 24, 2013

Please add the attached notification to the official docket 92S-0251.

On September 24, 2013, CDRH published the Final Rule on the Unique Device Identification System [See 78 FR 58786].  In addition to the requirement for unique device identifiers (UDIs) in human and AIDC-readable form to appear on the label of a device, labelers are also required to submit device identifiers and other product information to the Global Unique Device Identification Database (GUDID).  CDRH has developed a tool for web-based submission of device product information, but will also accept submission in HL7 SPL format  -  per the implementation specification found in the attached document.  The GUDID submission process accepts no paper documentation, at this time.
CDRH has published a collection of implementation documents, HL7 SPL Implementation Files, to assist in the generation of HL7 SPL formatted GUDID submissions.  The attached document "Global Unique Device Identification Database (GUDID): Health Level 7 (HL7) Structured Product Labeling (SPL) Implementation Specification" can be found in this collections and  it provides detailed instructions for building a valid HL7 SPL xml document for submission.  This method of submission can be used by individual submitters or third-party solution providers.  Please note:  there are additional steps to complete when contracting a third-party to submit on your behalf.  
Additional information about necessary steps to complete prior to HL7 SPL submission can be found in the document, "Global Unique Device Identification Database (GUDID): Draft Guidance for Industry".
All HL7 SPL documents and the GUDID Draft Guidance document can be found at:  www.fda.gov/udi. 


