FDA's New Import Program for 2020

New import requirements are being brought into effect by the FDA and U.S. Customs and Border Protection. The commonality between these two programs, the FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program, is that they both require more information from the foreign source(s) from which the import arrives.

These requirements are linked electronically through the FDA's product codes and U.S. Harmonized Tariff Schedule (HTS). The main requirement of this linking process is that the software coding information must be correct, failing which an importer could face all sorts of hassles that range from cost-incurring delays to possible refusal of the entry.

These requirements also demand consistency of the information on the entry's commercial or proforma invoice with the information entered into PREDICT and ACE software. There is, however, a saving grace, in that the FDA offers some relief from the strict requirements for importers that participate in a voluntary Affirmation of Compliance (AOC).

It is thus absolutely essential for importers to provide accurate information that reconciles and matches the information contained in all these: the PREDICT, ACE, Invoice and AOC. Consistency in the information provided in these sources ensures smooth passage of the imported goods to their intended destination. Failure to do so can be disastrous: a flood of expensive delays and fines. It has to also be borne in mind that time is of the essence. It is as powerful and valuable as money; the more the importer uses, the more it loses.

Proper learning on all the aspects of these new requirements, vital towards ensuring smooth passage of the imported goods into the US, will be offered at a webinar that Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing on January 8.

Compliance4All brings the ideally suited expert for this webinar: Casper Uldriks, an ex-FDA Expert and former Associate Center Director of CDRH. Who could be better placed to offer insights into these new requirements than Casper, who brings rich experience of having worked for the FDA for 32 years?

Please enroll for this valuable session by visiting Compliance4all

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Although the FDA’s new import entry filing requirements became effective in January 2016, misgivings and misinformation abound, making it easy for importers to fall prey to these and inviting hefty penalties. Getting it right smoothens the entire import process. Casper will show how to streamline this linking information and ensure that the imported items find a safe and hassle-free passage into the US and reach their desired destination.

He will show how to use the many kinds of information that is available to check the entry status and the communication that has taken place between the importer’s broker and the US Customs.

The following areas will be covered at this webinar:

• 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)

This webinar is aimed at benefiting 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, and Sales Managers.

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About the speaker:

Casper Uldriks, who owns the firm, Encore Insight LLC, specialized in the FDA's medical device program as a field investigator, and 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.

Over 32 years of having worked with the FDA, he understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA's domestic and international operational programs, institutional policy a

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations.