Mar 6, 2018
EMERGO SUMMARY OF KEY POINTS:
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.
EMERGO SUMMARY OF KEY POINTS:
Medical device market regulators in the US have launched a new website to provide public access to their Global Unique Device Identification Database (GUDID) designed to store device labelers’ information about their products.
EMERGO SUMMARY OF KEY POINTS: