Several Class III medical device manufacturers have already employed the Reed Tech GUDID Submission Service to assist in accurate and timely submissions for GUDID compliance. In addition, many Class II manufacturers have contracted with Reed Tech to begin the initial phases of data collection and validation and will utilize the Reed Tech GUDID solution for UDI submissions within the upcoming months.
Manufacturers of Class III medical devices must comply with the FDA Final Rule on medical device UDI with a successful submission to the FDA by September 24, 2014. Now facing pressure to meet the upcoming Class III deadline for compliance, multiple Class III manufacturers have turned to Reed Tech for accurate and timely submissions to the GUDID. As of August 25, 2014, Reed Tech has successfully submitted multiple data records to the GUDID on behalf of several Class III manufacturers and is working with dozens more in preparation of submission in the weeks to come.
Submissions to the GUDID may be made in one of two methods: FDA Web Interface or HL7 SPL submission. There are several options for HL7 SPL submission and Reed Tech provides manufacturers with two approaches for submission: Software as a Service (SaaS) and Outsourced Service. These service options, in particular, allow medical device manufacturers ease of use since timely internal installation and validation procedures are not necessary. A medical device manufacturer may make submissions to the GUDID within days of choosing Reed Tech as a service provider.
Groups of internal Reed Tech UDI Subject Matter Experts have worked to create an accurate validation tool within the Reed Tech GUDID solution. For the past several months, Reed Tech has been working closely with the FDA to develop an accurate GUDID submission service. Participation in both Pilot SPL and High Volume ESG Load Testing Programs with FDA has enabled Reed Tech to build a comprehensive validation engine within the Reed Tech GUDID Solution.
With less than one month left for Class III manufacturers to meet FDA UDI compliance deadlines, manufacturers who have not yet chosen a solution for submission must do so now. For more information on how Reed Tech can assist with medical device GUDID submissions, please contact an account executive today at 800-772-8368.