Class II Devices, Implantables Lead the Way in GUDID Data
Posted March 20, 2018
The Food and Drug Administration’s (FDA) Global Unique Device Identification Database (GUDID) now has more than 1.6 million records of medical devices registered for sale in the United States. Of these, more than 80% are from Class II devices, and nearly half are associated with implantable devices, according to a report released by the FDA in early March.
The prevalence of Class II devices in the database is not unexpected since 43% of medical devices fall into this moderate-risk category, based on FDA statistics. This class of devices includes powered wheelchairs, infusion pumps, hemodialysis machines, and surgical drapes.
In terms of FDA product codes, orthopedic devices make up more than 35% of GUDID entries, followed by dental and general and plastic surgery devices.
GUDID submissions are part of a broader set of unique device identification (UDI) requirements imposed by the FDA in September 2013. According to the final rule, low-risk Class III devices were required to submit data to GUDID by September 2014; implantable, life-supporting, and life-sustaining devices had until September 2015; and Class II devices had until September 2016.
However, the deadline was extended for certain Class II devices, including repackaged single-use devices and some types of so-called “convenience kits,” until September of this year. The FDA also has extended the enforcement of UDI labeling and GUDID data submission requirements for medical devices that generally present a lower risk to patients (certain Class I and unclassified devices), such as manual surgical instruments and mechanical wheelchairs. Class I and unclassified devices manufactured and labeled on or after Sept. 24, 2018 have until Sept. 24, 2020 to comply, while finished Class I and unclassified devices manufactured and labeled before Sept. 24, 2018 have until Sept. 24, 2021.