Two-Day Virtual FDA Import Training Course: Dealing with FDA Import Delays Including COVID-19, Expedited Imports and Detentions (January 20-21, 2022)


Dublin, Nov 30, 2021 (GLOBE NEWSWIRE) – The ‘Dealing with FDA Import Delays including COVID-19, Expedited Imports and Detentions’ training has been added to offer.

The FDA continues to modify its import program to better manage emerging issues and to use new procedures to facilitate the entire process.

The FDA and US Customs and Border Protection (CBP) increasingly rely on computer programs to speed up the import process. When and how you use these programs can make a big difference in the bottom line of a single shipment. The new Voluntary Qualified Importer (VQIP) program is one example.

Another example is CBP and FDA’s implementation of the Automated Commercial Environment (ACE) program which became mandatory for importers in 2016. If you do not properly use the new import procedures and programs, you will suffer a costly disadvantage.

Learning objectives:

  • New FDA Cost-Effective Import Programs
  • Understand how U.S. Customs and FDA legal requirements intersect
  • Know how to manage foreign suppliers
  • Understand FDA internal procedures
  • Find out how to mitigate and resolve import retention
  • Learn how to avoid common problems
  • Develop practical ways to improve your import and export business
  • You will be able to answer the following questions with this course without saying “I don’t know?” “
  • What are the FDA’s legal requirements and import policy?
  • How do you handle FDA and US Customs and Border Patrol procedures?
  • What happens when your product is detained?
  • What if a foreign manufacturer has issues with the FDA?
  • How do you interact with the FDA to resolve issues?
  • Why are import and export rules different or even important?

Main topics covered:

Day 01 (8:30 am – 2:30 pm PST)8:30 am: Beginning of the session

Day 1 – Morning

FDA legal requirements

  • Statutory authority
  • Regulations

Obligations of foreign manufacturers

  • Initial obligations of US importers
  • Cost of using
  • How the FDA does its job
  • What is CPB and how do they do their job

Selection of foreign suppliers

  • Inspection history
  • Samples analyzed
  • Supplier audit

Day 1 – Afternoon

PProduct import procedures

  • Entry process (US Customs / FDA)
  • How to Choose the Right Custom House Broker
  • Documentation
    • FDA Form 2877
    • Form CPB 3461
    • Medical Device Conformity Affirmations (AofC)
    • Electronic entry deposit
      • FDA PREDICT Computer Screening Program
      • US Customs Automated Commercial Environment (ACE) Program
      • Product sampling / testing
      • Detention, block list, automatic detention
    • Quality standards
    • Native country
    • Type of product

(Case study)

Day 02 (8:30 am – 2:30 pm PST)

Day 2 –Morning

Foreign inspections by the FDA and EU Notified Bodies


  • Options for a retained shipment
  • Negotiate with the FDA and US Customs
    • What to say
    • What not to say
    • When to give up
  • Release from detention and recourse by the government in the event of refusal
  • Reduce the risk of detention

(Group study to mitigate the risks associated with detention)

Day 2 – Afternoon

FDA warning letters and automatic detention

  • Enforcement
  • US Customs Authority and FDA
  • Burden of proof
  • Assistant lawyer in the United States
  • Government remedies

Special provisions

  • Counterfeit
  • Import to export
  • International trade fairs
  • Investigation device
  • “Compassionate use”

New special issues for imports and exports in 2020.

  • EU Medical Device Regulation (MDR) program for imported products
  • Personal mail inspection
  • Personal use exception
  • Trade shows and promotional marketing
  • Compassionate use.

For more information on this training, visit

         Laura Wood, Senior Press Manager
         [email protected]
         For E.S.T Office Hours Call 1-917-300-0470
         For U.S./CAN Toll Free Call 1-800-526-8630
         For GMT Office Hours Call +353-1-416-8900

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