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Medical Device Imports - FDA's New Import Program Concerning International Consequences

By:
Casper E. Uldriks, Former Associate Center Director of FDA's CDRH
Coming soon.. Please contact customer care for new schedule

Course "Medical Device Imports - FDA’s New Import Program Concerning International Consequences" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

FDA’s import and export program is complex and keeps changing. The FDA’s and the U.S. Custom’s new import and enforcement program operates with a streamlined computer system and can leave firms at a loss to understand the short term and long term effects of a detained shipment. The law now requires foreign firms to register and submit specific information to enter U.S. commerce.

Foreign establishments are subject to FDA inspections and quality testing. Failing either FDA activity typically prevents a foreign firm’s product from entering U.S. commerce. If product is detained, resolving the problem with FDA is time consuming, expensive and uncertain. Without an adequate or informed approach to your import program, the specialized federal government process and roadblocks can seem impossible to overcome. To compound the problems, working with foreign establishments presents inherent difficulties based on cultural differences business practices and language barriers.

Other foreign and domestic and legal requirements intersect with FDA’s import and export program, some for the better, some not. For example, not all foreign firms are treated the same under the FDA’s law. A clear example is the FDA’s uses of automatic detention based on the country of origin, type of product or an establishment’s history. With the growing use of off-shore operations, managing imported products can and does present obvious and hidden problems. Understanding all of these and other issues related to product detentions and how to deal with it, how US custom’s laws and FDA laws intersect etc. is critical to a firm’s successful import business and help reducing the commercial disadvantages it creates.

Register for this conference to learn from an "Ex-FDA Official" who has spent 32 years in FDA and his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. He currently trains FDA personnel and counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA’s requirements.



Learning Objectives:

Key goals of the conference are :

  • Provide clarity to the FDA import program and process
  • Understand how U.S. Customs and FDA laws intersect
  • Learn how to avoid common and costly problems
  • Understand product detention and how to deal with it
  • Develop practical ways to improve your import and export business
  • Identify government programs designed to help


Who will Benefit:

The FDA’s regulatory controls for imported and exported devices have become increasingly pervasive and stringent. Foreign manufacturers, foreign exporters and domestic initial importers face greater scrutiny and are subject to expensive consequences if they do not plan carefully. Attendees need to understand the FDA’s and the US Customs Border Patrol’s regulatory criteria, inter-agency agreements and intra-agency procedures. The conference provides attendees with the opportunity to understand their work’s inter-relationship with other attendees’ roles.

  • 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



Course Outline:

Day One (8:00 AM – 4:30 PM) Day Two (8:00 AM – 4:30 PM)

Day 1 / Morning

FDA’s legal requirements

  • Statutory authority
  • Regulations
  • Foreign manufacturers obligations
  • U.S. initial importers obligations
  • User Fees

Day 1 / Afternoon

Product Import Procedures

  • Entry Process (U.S. Customs/FDA)
  • Documentation
  • FDA’s PREDICT computer screening program
  • Product sampling / testing
  • Detention, block list, automatic detention
    • Quality standards
    • Country of origin
    • Product type

(Case Study)

Day 2 / Morning

Detention

  • Options for a detained shipment
  • Negotiating with FDA and U.S. Customs
  • Release from Detention and Government Refusal Remedies
  • Reducing the risk of detention

(Group study for mitigating detention risks)

Day 2 / Afternoon

Enforcement

  • U.S. Customs and FDA authority
  • Burden of proof
  • Assistant U.S. attorney
  • Government remedies

Special provisions

  • Counterfeit
  • Import for export
  • International trade shows
  • Investigational device
  • “Compassionate Use”



Meet Your Instructor

Casper (Cap) Uldriks
Former Associate Center Director of FDA's CDRH

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. Mr. Uldriks specialized in the FDA’s medical device program as a field investigator, senior manager in the Office of Compliance and as an Associate Center Director in the Center for Devices and Radiological Health. He developed enforcement actions, participated in the implementation of new statutory requirements, managed device regulatory programs and was recognized as the agency’s expert in a number of statutory provisions and regulations. Starting in 1995, he trained the FDA’s investigators on the FDA’s legal authority and CDRH’s regulatory requirements and procedures. He continues to teach the FDA’s employees to this day. He is recognized and sought out as an exceptional and energetic speaker. Many of his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. His comments are candid and of practical value. He understands how the FDA thinks, operates and where it is headed.

He also served in the FDA’s Office of Legislative Affairs for 5 years as the FDA’s congressional liaison for its medical device program. As a federal “Legislative Fellow” he worked for one year in a congressional subcommittee for the Energy and Commerce Committee where he drafted proposed FDA legislation for the regulation of human tissue. He managed and wrote testimony for the Commissioner for several congressional oversight hearings concerning FDA’s device program.

He now works almost exclusively on medical device issues at Olsson, Frank, and Weeda (OFW Law) in Washington, D.C. He counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA’s requirements.




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