This seminar is intended to assist with a basic overview of what medical devices are...
Many companies that import medical devices are either unaware that the product is in fact a medical device, or unaware of FDA’s requirements related to medical devices. This seminar is intended to assist with a basic overview of what medical devices are, how to identify if you are in fact importing one, and if so, what the FDA’s requirements really are to do so.
Areas Covered in the seminar:
Seminar is to inform the international trade and transportation community regarding the FDA policies and procedures related to medical devices.
- What is a Medical Device?
- Checklist Best Practices for Importing Medical Devices
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- Medical Devices Classes.
- Premarket Notification - 510 (k).
- Premarket Approval (PMA).
- Establishment Registration FDA Form 2891.
- Quality System Regulation (QSR).
- Due Diligence - Medical Device Reporting.
- Medical Device Listing FDA Form 2892.
Who Will Benefit:
- Importers
- Customs Brokers
- Warehouses
- Air and Ocean Carriers
- Trucking companies
- Consultants
- International attorneys
- International Bankers
- Others interested in medical devices
Instructor Profile:
Jennifer Diaz, is an attorney in the Firm’s International Business, Trade & Customs Law Practice Group. She concentrates her practice on assisting clients with issues relating to the import and export of goods to and from the United States.
She has experience working with Federal agencies including the U.S. Food & Drug Administration, U.S. Customs and Border Protection, U.S. Department of Homeland Security, U.S. Environmental Protection Agency, and Alcohol and Tobacco Tax and Trade Bureau on issues relating to classification assessments of medical devices; labeling review of food, over-the-counter (OTC) drugs, and medical devices; FDA voluntary recalls; classification of goods; antidumping matters; scope ruling requests; forfeitures, seizures, and mitigation of penalties; Customs-Trade Partnership Against Terrorism (C-TPAT); trademark recordation and infringement.
During law school, Ms. Diaz clerked at Becker & Poliakoff, P.A., as well as for Judges Beth Bloom in Miami Dade and Susan Lebow in Broward counties. She also served as a legal intern for Legal Aid Services and the City of Hallandale Beach.
