FDA's New Import Program for 2019

Added 2 months ago by Joseph Wilcox on Medical ethics
Overview
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s).

FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC).

Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.

Why should you Attend
The new import entry filing requirements became effective in 2016 and are posing problems for user. Failure to provide the correct information creates costly delays and, in some cases, the frustrating task of contacting the FDA to resolve the problem.

FDA's software screening program, PREDICT, and U.S. Custom's ACE program require careful attention. Errors will cost money. The less obvious software is the FDA's and U.S. Custom's linking of your legal requirements by using the correct Harmonized Tariff Schedule (HTS) code. That sets up how FDA will apply its requirements.

In addition, the information on the manifest, invoice and affirmation of compliance make importing easy provided you get it right. Making errors means FDA may flag you as a problem that requires greater scrutiny for data verification. As if delays and detentions are not bad enough, there will be punitive fines for filing incorrect entry data in ACE. This is a needless cost as long as you understand what you should be doing.

The benefits require the correct information for FDA and U.S. Customs software programs. At least now, using the PREDICT and ACE programs let you check the status of your entry and what the communications are between your broker and U.S. Customs. There is a lot of information at your fingertips now, if you get it right.

Areas Covered in the Session
FDA's required information for the PREDICT software screening prior to entry
FDA product codes
Custom's required information for the ACE software system prior to entry
Custom's Harmonized Tariff Schedule (HTS)
Affirmation of Compliance (AOC)
Who Will Benefit
Business Planning Executives
Regulatory Managers
In-house Legal Counsel and Contract Specialists
Venture Capitalists
Business Acquisition Executives
Owners of New or Developing Import/Export Firms
International Trade Managers
Import Brokers
Investors
Logistics Managers
Sales Managers
Speaker Profile
Casper (Cap) Uldriks through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value.


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