Medical Device Product Codes

Product Code Classification Database | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database

The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892. These files are updated every Sunday.

Product Codes and Product Code Builder | FDA

https://www.fda.gov/industry/import-program-tools/product-codes-and-product-code-builder

Example 3: Medical Device Product Code Product: First Aid Kit including drugs Product Code: 79L--RR. Example 3 - Medical Device Product Code; Structure …

Medical Device Classification Product Codes - Guidance …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-classification-product-codes-guidance-industry-and-food-and-drug-administration-staff

FDA Product Code Classification | NBER

https://www.nber.org/research/data/fda-product-code-classification

The name and product code identify the generic category of a device for FDA. The Product Code assigned to a device is based upon the medical device product …

Medical Device Regulation codes - Medical Device HQ

https://medicaldevicehq.com/articles/medical-device-regulation-codes/

The Medical Device Regulation codes, or MDR codes for short, specify what the notified bodies are designated for and thereby stipulate what category of devices the …

MDCG 2019-14 - Public Health

https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_14_mdr_codes_en_0.pdf

Medical Device Medical Device Coordination Group Document MDCG 2019-14 MDCG 2019-14 Explanatory note on MDR codes December 2019 This document has been …

Device Product Codes (procodes) for Device Constituent …

https://www.fda.gov/combination-products/device-product-codes-procodes-device-constituent-parts-andandabla-combination-products

1 Please note, while this information is helpful for efficient review of ICSRs for all combination products with a device constituent part, selection of a procode for device …