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Unified Medical Language System® (UMLS®)

Standard Product Nomenclature Source Information

Web site
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051637.htm

Authority
The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) developed and maintains the Standard Product Nomenclature.

Purpose
The nomenclature is used to share regulatory information about medical devices.

Description
The nomenclature contains the medical device names and associated information, such as product review codes, definitions, and classification regulation numbers, which reside in CDRH’s Product Code Classification Database.

Audience
The nomenclature is used by medical device regulators and manufacturers, healthcare professionals, and the general public for information about medical device approvals and classification.

Update Frequency
The nomenclature is updated monthly.

Metathesaurus Update Frequency
The nomenclature was last updated in the Metathesaurus in 2004.

Sites Consulted

  1. Product Code Classification Database [Internet]. Silver Spring (MD): Food and Drug Administration; [updated 2009 May 13; cited 2009 Dec 17]. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051637.htm; Download Product Code Classification Files: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051668.htm