CSMS #64764215•Wednesday, April 16, 2025
PGA UpdateMedium UrgencyAction Required
CSMS # 64764215 - Food and Drug Administration (FDA) End-Dating Center for Devices and Radiological Health (CDRH) Product Code and New Center for Drug Evaluation and Research (CDER) and Human Foods Program (HFP) Product Codes
CSMS # 64764215 - Food and Drug Administration (FDA) End-Dating Center for Devices and Radiological Health (CDRH) Product Code and New Center for Drug Evaluation and Research (CDER) and Human Foods Program (HFP) Product Codes U.S. Customs and Border Protection sent this bulletin at 04/16/2025 11:09 AM EDT CSMS # 64764215 - Food and Drug Administration (FDA) End-Dating Center for Devices and Radiological Health (CDRH) Product Code and New Center for Drug Evaluation and Research (CDER) and Human Foods Program (HFP) Product Codes The Food and Drug Administration (FDA) will be end-dating the Center for Devices and Radiological Health (CDRH) product codes listed below. The end-date will be in 30 days, on May 16, 2025. Product Code/Description 80L[][]DH/System, Delivery, Allergen and Vaccine The FDA has created new Center for Drug Evaluation and Research (CDER) product codes listed below. The product codes are available immediately. Product Code/Description 60C[][]61/Mirabegron (Adrenergic) 61M[][]50/Brivaracetam (Anti-Convulsant) 61M[][]51/Pregabalin (Anti-Convulsant) 62Z[][]71/Neratinib (Anti-Neoplastic - Part II) 65C[][]12/Dextrose (Nutrient/Tonic) The FDA has created new Human Foods Program (HFP) product codes listed below. The product codes are available immediately. Product Code/Description 16E[][]11/Scallops (Adductor Muscle only) 16F[][]11/Scallops (Adductor Muscle only), Breaded 16G[][]11/Scallops (Adductor Muscle only), Cakes, Balls, Etc. 16O[][]11/Scallops (Adductor Muscle only), Hot Smoked, Shellfish 16T[][]11/Scallops (Adductor Muscle only), Cold Smoked, Shellfish 16X[][]54/Scallops (Adductor Muscle only), Aquaculture Harvested Fishery/Seafood Products 16Y[][]19/Shellfish Roe, Fishery Products, n.e.c. 21R[][]49/Nance, Subtropical and Tropical Fruit Purees 21S[][]49/Nance, Subtropical and Tropical Fruit 21T[][]49/Nance, Subtropical and Tropical Fruit, Dried or Paste 21U[][]49/Nance, Subtropical and Tropical Fruit, Jams, Jellies, Preserves, Marmalades, Candied, Butters, Spread 21V[][]49/Nance, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars 21W[][]49/Nance, Subtropical and Tropical Fruit, Toppings or Syrups 21X[][]49/Nance, Subtropical and Tropical Fruit Pulp Please send any questions or concerns to the email address for the Product Code Builder Feedback: PCBFeedback@fda.hhs.gov . For assistance with product code identification, the public may also refer to the FDA Product Code Builder . Update your subscriptions, modify your password or e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page . You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact subscriberhelp.
Additional Information
Programs Affected:
ACE
PGAs Affected:
FDA