FDA Releases Unique Device Identification Final Rule, Draft Guidance

by BakerHostetler

On September 24, 2013, the Food and Drug Administration (FDA) published a Final Rule, which will, over the next several years, require many medical devices distributed in the U.S. to carry a unique device identifier (UDI). According to the accompanying FDA Press Release, the UDI system is intended to provide a consistent method of identifying medical devices and improve the quality of information received by the FDA in its medical device adverse event reports, thereby improving patient safety. The FDA also released Draft Guidance for Industry intended to outline the process for submitting information to the UDI system.

The Final Rule comes more than a year after the FDA's July 2012 Proposed Rule requested input from industry, the clinical community and patient and consumer groups regarding device identification and postmarket surveillance. The UDI system also is a key component of the FDA's September 2012 and April 2013 National Medical Device Postmarket Surveillance Plan.

Under the Final Rule, a UDI will be assigned to most medical devices. The UDI will be a unique numeric or alphanumeric code consisting of two components. The first component is the mandatory device identifier (DI) portion, which identifies the manufacturer and specific version or model of a device. The second component is the variable production identifier (PI) portion, which identifies a device's lot or batch number, serial number, expiration date, manufacture date or other similar information.

The Final Rule also creates the Global Unique Device Identification Database (GUDID), a publicly searchable database administered by the FDA to serve as a reference catalogue and include a standard set of basic identifying elements for every device labeled with a UDI. According to the FDA, the UDI does not indicate, and the GUDID will not contain, "protected health information" under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

The FDA plans to implement the UDI system in phases, focusing first on high-risk medical devices. Many low-risk medical devices will be exempt from some or all of the requirements of the Final Rule. By September 24, 2014, high-risk medical devices (including most Class III medical devices) generally will be required to carry the UDI on their label and packaging, and manufacturers of these devices will be required to submit data to the GUDID. Devices intended for reuse that require reprocessing before each use also must be permanently marked with a UDI directly on the device. Devices that are implantable, life-supporting or life-sustaining generally will be subject to similar UDI and GUDID requirements. Manufacturers of moderate-risk devices (including most Class II medical devices) will have three years to comply with the provisions of the Final Rule. Manufacturers of low-risk medical devices (Class I medical devices) that are not exempted from UDI requirements will have five years to comply with the Final Rule. However, a Class I device exempted from the FDA's good manufacturing practices requirements also will be exempted from UDI requirements. In addition, devices manufactured and labeled prior to the FDA's compliance date for that class of devices also are exempt from the UDI requirements, but this exemption expires three years after the applicable compliance date.

The FDA's GUDID Draft Guidance for Industry is intended to help manufacturers prepare to submit information to the database. In order to further clarify any issues that may arise during implementation of the GUDID, the FDA has requested comments and suggestions regarding the Draft Guidance. The Draft Guidance also raises important issues regarding provider tracking of UDI information and adverse event reporting. Providers should consider this information in developing recordkeeping and reporting policies and procedures.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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