The U.S. Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA) will host an informational session to discuss updates to the FDA Automated Commercial Environment (ACE) Final Rule and the most common reasons for FDA entry rejections and shipment delays.   The speakers with be from the Division of Import Operations and they provide an overview on the use of the Supplemental Guide, provide answers to frequently asked questions, and disseminate contact information for FDA personnel working in import operations.

Overview of ACE and FDA

• How ACE Works for FDA
• FDA Current Status
• Most Common CBP and FDA Rejections
• Common Data Errors
• FDA Flags
• FDA ACE Final Rule Changes

Commodity Specific Information (Medical Devices and Food)

• Know the Product Being Imported
• Information Needed for Submission
• Common Reasons for Commodity Specific Entry  Processing Delays
• Commodity Specific Resources

Information and Resources for All FDA Regulated Products

• Avoiding Delays with FDA
• Use the Supplemental Guide
• Summary
• Frequently Asked Questions
• Resources
• FDA Points of Contact for Imports

SPEAKERS:

Jessica Aranda works in the Division of Systems Solutions within the Food and Drug Administration’s Office of Regulatory Affairs. Ms. Aranda serves as a subject matter expert and business process manager for ACE, focusing on improving processes and efficiency. Previously, Ms. Aranda served in the U.S. Marine Corps as a photojournalist and media relations coordinator. She earned a M.S. in Public Relations and Corporate Communication from New York University and a B.A. in Journalism with an emphasis in Public Relations from San Diego State University.

Brigitte Strelnik is a Consumer Safety officer in the Division of Import Program Development (DIPD) within the Food and Drug Administration’s Office of Regulatory Affairs, where she serves as a subject matter expert for ACE Operational Questions and a center liaison for the Center for Devices and Radiological Health (CDRH). Prior to Brigitte’s position in DIPD, she was a consumer safety officer for the Cincinnati District office where she performed domestic and foreign medical device inspections, import entry review for all commodities, field examinations for imported products, and she served as the filer evaluation coordinator for a few years. Brigitte earned her B.S. in Biomedical Engineering from the University of Cincinnati.

LOCATION: Topco Building

TIME: 2-4 pm