FDA: GUDID Data Primarily from Class II and Implantable Medical Devices (So Far)

EMERGO SUMMARY OF KEY POINTS:

• The FDA GUDID database now has more than 1.6 million records of medical devices registered for sale in the US.
• Most GUDID data is from Class II devices, and almost half of GUDID records cover implantable devices.
• So far, orthopedic devices account for 35% of GUDID device records.

The US Food and Drug Administration has published a brief report showing that as of March 1, 2018, most data submitted to the Global Unique Device Identification Database (GUDID) pertains to Class II devices, and that nearly half of GUDID data comes from implantable devices.

According to the agency’s analysis, more than 1.6 million records currently exist in GUDID; more than 80% of those records are for Class II devices, while nearly 50% of records are for implantable devices.

In terms of FDA product codes, orthopedic devices make up more than 35% of GUDID records, with dental products as well as general and plastic surgery devices coming in at under 15% each.

GUDID submissions are part of broader Unique Device Identification (UDI) requirements imposed by FDA; the prevalence of Class II device records in the database reflects the fact that most devices commercialized in the US are cleared by FDA as Class II under the 510(k) premarket notification pathway.

Additional US FDA and UDI resources from Emergo:

• US FDA 510(k) consulting for medical device and IVD manufacturers
• Medical device UDI consulting and training
• Video overview: The US FDA UDI system
• Whitepaper: Understanding US UDI requirements