FDA offers New Import Program for 2017

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.

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.

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

Speaker and Presenter Information

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.