CSMS# 17-000437 - FDA AVAILABILITY OF NEW CDRH PRODUCT CODE FOR GENERAL WELLNESS PRODUCTS
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08/02/2017 10:25 AM EDT
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Update to Food and Drug Administration Related to General Wellness Products
The US Food & Drug Administration (FDA or the Agency) has created a new product code for low risk devices promoted as general wellness products. Product code 80P[][]WC is now available for import use only. This product code should not be used for FDA device registration purposes under any circumstances.
To determine if your product falls within the general wellness scope and for guidance on appropriate use of this product code, please review the published guidance on www.fda.gov. at General Wellness: Policy for Low Risk Devices (https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf).
This product code, 80PWC, should be transmitted with Intended Use Code 081.006. This information will be included in the next version of FDA’s Supplemental Guide. Questions related to the FDA reporting requirements for general wellness products may be submitted to CDRH OC Import Mailbox cdrhocimport@fda.hhs.gov
Questions related to the transmission of these data elements via ACE may be submitted to FDA ACE Support, ACE_Support@FDA.HHS.GOV or 877-345-1101 from 6AM to 10 PM Eastern
Update to Food and Drug Administration Related to General Wellness Products
The US Food & Drug Administration (FDA or the Agency) has created a new product code for low risk devices promoted as general wellness products. Product code 80P[][]WC is now available for import use only. This product code should not be used for FDA device registration purposes under any circumstances.
To determine if your product falls within the general wellness scope and for guidance on appropriate use of this product code, please review the published guidance on www.fda.gov. at General Wellness: Policy for Low Risk Devices (https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf).
This product code, 80PWC, should be transmitted with Intended Use Code 081.006. This information will be included in the next version of FDA’s Supplemental Guide. Questions related to the FDA reporting requirements for general wellness products may be submitted to CDRH OC Import Mailbox cdrhocimport@fda.hhs.gov
Questions related to the transmission of these data elements via ACE may be submitted to FDA ACE Support, ACE_Support@FDA.HHS.GOV or 877-345-1101 from 6AM to 10 PM Eastern
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