The first deadline for the UDI rule is approaching. The FDA released their final rule for UDI on September 20, 2013. Most medical devices will require a UDI or Universal Device Identifier within the next seven years. The UDI will have many benefits such as improved product information and faster product identification for problems or recalls. The following timeline shows when certain devices are required to have a UDI label.
September 24, 2014 – Class III devices and software; devices licensed under the US PHS Act
September 24, 2015 – Implantable, life-supporting and life-sustaining devices and software
September 24, 2016 – Class II devices; direct marking for Class III devices for some uses
September 24, 2018 – Class I devices; devices not classified as Class I, II or III; direct marking of Class II devices for some uses
September 24, 2020 – Direct marking of Class I devices and devices not classified as Class I, II or III for some uses
The FDA has released a training guide for assistance in compliance with the UDI rule. The training guide covers topics such as: UDI overview, how to request a GUDID, and how to get started with a GUDID.
FDA has accredited the following agencies for UDI:
| 1. | FirmName: GS1 Address: Princeton Pike Corporate Center, 1009 Lenox Drive, Suite 202, Lawrenceville, NJ 08648 Contact Person: Siobhan O’Bara, Senior Vice President – Industry Engagement Phone: (609) 620-8046 Email: sobara@gs1us.org Web Site: http://www.gs1.org Date of Initial Accreditation: December 17, 2013 Initial Accreditation Granted through: December 17, 2016 |
| 2. | Firm Name: Health Industry Business Communications Council (HIBCC) Address: 2525 E. Arizona Biltmore Circle, Suite 127, Phoenix, AZ 85016 Contact Person: Robert A. Hankin, PhD., President and CEO Phone: (602) 381-1091 Email: rhankin@hibcc.org Web Site: http://www.hibcc.org Date of Initial Accreditation: December 26, 2013 Initial Accreditation Granted through: December 26, 2016 |
| 3. | Firm Name: ICCBBA Address: PO Box 11309, San Bernardino, CA 92423-1309 Contact Person: Pat Distler, Technical Director Phone: (909) 793-6516 Email: pat.distler@iccbba.org Web Site: http://www.iccbba.org Date of Initial Accreditation: February 12, 2014 Initial Accreditation Granted through: February 12, 2017 |