CSMS# 18-000155 - FDA ACE PGA Message Set Validations for Medical Device Products
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02/22/2018 11:01 AM EST
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FDA will be implementing ACE PGA Message Set validations for medical devices tonight, February 22, 2018, for the following:
1. If Program code is DEV and Intended Use Code is 081.001, 081.002, or 081.004, then PG19 Manufacturer country code in PG20 CANNOT = US
2. If Program code is DEV, then PG19 Device Initial Importer country code in PG20 MUST = US
Failure to transmit data per the above rules will result in an FDA rejection. These validations are in line with FDA’s Supplemental Guide. For technical questions or assistance, contact the FDA ACE Support Center at 1-877-345-1101 or ACE_Support@fda.hhs.gov.
FDA will be implementing ACE PGA Message Set validations for medical devices tonight, February 22, 2018, for the following:
1. If Program code is DEV and Intended Use Code is 081.001, 081.002, or 081.004, then PG19 Manufacturer country code in PG20 CANNOT = US
2. If Program code is DEV, then PG19 Device Initial Importer country code in PG20 MUST = US
Failure to transmit data per the above rules will result in an FDA rejection. These validations are in line with FDA’s Supplemental Guide. For technical questions or assistance, contact the FDA ACE Support Center at 1-877-345-1101 or ACE_Support@fda.hhs.gov.
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