FDA s New Import Program for 2019
Learn what FDA's PREDICT screening and CBP's ACE system require at entry, how product and HTS codes link the rules, and how AOCs help imports clear without costly delays.
Speaker
Casper E Uldriks
Former FDA CDRH associate director · Encore Insight LLC · Former FDA investigator
Overview
The FDA and U.S. Customs and Border Protection require more information on imported products than before. FDA's PREDICT screening software and Customs' ACE system both need data from the foreign source, and FDA product codes and Harmonized Tariff Schedule (HTS) codes link the legal requirements.
This 60-minute webinar on FDA import requirements explains what each system needs before entry. If the coding is wrong, you face costly delays, possible entry refusal, extra FDA scrutiny and fines for incorrect ACE data.
You'll also see why the commercial or pro forma invoice must match what is entered in PREDICT and ACE, and how a voluntary Affirmation of Compliance (AOC) can ease the requirements.
Why attend: The entry filing requirements took effect in 2016 and still cause problems for importers. Getting the information right avoids delays and detentions, and lets you track your entry's status and your broker's communications with Customs. This session suits business planning and acquisition executives, regulatory managers, in-house counsel, investors, import/export business owners, international trade, logistics and sales managers, and import brokers.
What’s covered
- FDA's required information for PREDICT screening before entry
- FDA product codes
- Customs' required information for the ACE system before entry
- The Customs Harmonized Tariff Schedule (HTS)
- Matching invoice and manifest information with PREDICT and ACE
- Affirmation of Compliance (AOC)
Who should attend
What you get
About the speaker
Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
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