Three new FDA import updates

FDA has been and continues to be a very active PGA when it comes to ACE matters:fda1

 

1.  Submission of FDA data in ACE

As discussed in a previous blog post, CBP and FDA are working to implement changes related to FDA’s Final Rule on Submission of Food and Drug Administration Import Data in ACE  and corresponding Supplemental Guide. The first deployment occurred on January 5, 2017, and a second is to occur today.

2.  Common FDA rejects in ACE
In an effort to keep the trade community aware of how ACE is progressing for FDA transmissions, FDA has identified the most common FDA (bucket 2) rejects.• Invalid Product Code• Invalid Food Facility Registration Number• Mismatch between Food Facility Registration and Manufacturer

• Invalid state/zip code combination

• Foreign Consignee

• Duplicate Entry

• Missing or incomplete entity address

For specific information related to the various FDA error codes, please refer to FDA’s Error Guide.

3.  FDA Requirements Change for Medical Devices, IUC 081.005

The requirements for transmitting medical device constituent parts for drug-device IND combination products, Intended Use Code 081.005 have been changed.

The following Affirmations of Compliance for IUC 081.005 are now conditional: DEV, DFE, LST. These Affirmations of Compliance are in addition to DA and IND, which are already indicated as conditional. This change will be reflected in the next version of FDA’s Supplemental Guide

 

For questions on any of the foregoing, contact FDA ACE Support

ACE_Support@fda.hhs.gov or 877-345-1101 or 571-620-7320

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.