FDA Makes Several Announcements

FDA announced that the final rule for the Unique Device Identification (UDI) system means that once the UDI system is implemented, there will be a consistent way to identify medical devices and facilitate more accurate reporting, reviewing, and analyzing of postmarket device data. This means that there will be a standard way to document device use in EHRs, clinical information systems, claim data sources, and registries.

As discussed at the AdvaMed 2013 Conference held September 23-25 in Washington D.C., AdvaMed had been working with the FDA over the past several years to help maximize the usefulness and value of any potential UDI system. FDA has worked closely with not only industry but also with the clinical community and patient groups in developing this rule.

The UDI system has two core components. The first step is to have the device manufacturer assign a unique number called the UDI to the version or model of a device. The identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing data when the information is put on the label.

The second component will include a publicly searchable database to be administered by the FDA called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center.

When devices are recalled, the identification system will improve the accuracy and specificity of adverse event reports, provide the foundation for a global secure distribution chain to help address counterfeiting and diversion. Eventually the hope is that the UDI system will lead to the development of an internationally harmonized medical device identification system.

FDA plans to phase in the UDI system, focusing first on high-risk medical devices such as heart valves and hip prostheses with devices such as powered wheelchairs and blood glucose meters to follow.  Many low-risk devices will be exempt from some or all of the requirements in the final rule.

In general, Class III high-risk medical devices will be required to carry UDIs on their label and packaging within one year with the number and corresponding device information submitted to the new database.  However, Class III device manufacturers can petition to extend the one-year implementation deadline based on public health and supply disruption issues.

With most Class II moderate risk medical devices, manufacturers will have three years to act, and manufacturers of Class I devices that are not exempt from UDI requirements will have five years to act.

In another FDA action, FDA also issued the final guidance for the developers of mobile medical apps. The agency intends to exercise enforcement discretion for the majority of mobile apps as they pose minimal risk to consumers.

The FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended. FDA is focusing are medical apps that are intended to be used as an accessory to a regulated medical device and medical apps that can transform a mobile platform into a regulated medical device.

Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices. FDA does not regulate the sale or general consumer use of smartphones or tablets nor does it regulate mobile app distributors.

For more information, go to www.fda.gov.