FDA 101 Archives - Customs & International Trade Law Firm

FDA 101

Cecilia — Thu, 06 Nov 2025 13:00:22 +0000

FDA is the federal agency that is responsible for overseeing most of the U.S. food supply, medical devices, drugs, cosmetics, vaccines, and tobacco products. FDA is responsible for protecting the public health by ensuring the safety and security of these products.
Recent changes in the broader regulatory environment and advancements in technology are shifting the way the FDA operates.

In this webinar, presenters discuss:

The New Policy, Legal, and Regulatory Landscape
FDA & Artificial Intelligence: Promise and Prospect
FDA’s Human Foods Program
What Importers Need to do Now in the New FDA Environment

Presenters:

Jennifer Diaz, President, Diaz Trade Law
Rick Quinn, Of Counsel, Diaz Trade Law

Who should attend?

Importers
Manufacturers
Customs Brokers
Regulatory Affairs Professionals
In-house Legal Counsel
Product Development Managers
Others interested in FDA

Getting MoCRA Compliant

Cecilia — Tue, 09 Jan 2024 00:51:58 +0000

Cosmetics companies must comply with the new requirements of the Modernization of Cosmetic Regulations Act by July 1, 2024. Diaz Trade Law will host a “Getting MoCRA Compliant” webinar on January 24. DTL President Jennifer Diaz and Of Counsel Rick D. Quinn will cover what companies need to know and do to prepare for the July deadline.

In This Webinar You Will Learn:

WHAT: is required NOW under the new MoCRA law.
HOW: to comply with the new rules and PREPARE for what’s coming.
WHERE: to find the most important information For MoCRA Compliance.
WHEN: are the important deadlines to be ready On Time.
WHY: MoCRA compliance is important To Avoid FDA Enforcement.

And more!

Tips on FDA’s Medical Device Registration Process

Jennifer Diaz — Thu, 27 Oct 2022 18:08:02 +0000

This 30 minute webinar provides a brief overview of establishment registration requirements FDA imposes when importing a medical device. Webinar attendees will learn who has to register, and how to properly register a medical device establishment.

In This Webinar You Will Learn:
– Who is required to register and list a medical device prior to importing into the U.S.?
– What is the FDA registration process?
– How many websites are involved?
– When does the FDA registration renew?
– Tips on when to apply
– How to update an establishment registration
– Attendees will receive the “Top 10 Tips When Importing Medical Devices”

Presenters:
– Jennifer Diaz

Who Should Attend:
– Importers
– Customs Brokers
– Regulatory Affairs Professionals
– In-house Legal Counsel
– Product Development Managers
– Consultants
– Others interested in FDA

Importing Food in Compliance With U.S. FDA and Surviving A FSVP Audit

Jennifer Diaz — Wed, 08 Sep 2021 18:41:01 +0000

This one-hour webinar provides an overview of the Food Safety Modernization Act (“FSMA”). The U.S. Food and Drug Administration (FDA) is now more than ever enforcing its Foreign Supplier Verification Program (FSVP) regulations. With over 58 Warning Letters issued against companies for FSVP violations, this webinar is crucial for food importers. This webinar explains the requirements of the FSMA FSVP rule and its implications on US food importers and foreign suppliers. Presenters provide top tips for how to develop an FSVP plan and how to pass an FSVP Audit.

In This Webinar You Will Learn:
– The Procedure and Requirements for Importing Food Products
– The Foreign Supplier Verification Program (FSVP) Requirements
– How to Comply with FSVP
– Surviving an FSVP Inspection

Presenters:
– Jennifer Diaz
– Denise Calle
– Domenic Veneziano

Who Should Attend:
– Importers
– Foreign Food Suppliers
– U.S. Food Importers
– Customs Brokers
– Regulatory Affairs Professionals
– In-house Legal Counsel
– Product Development Managers
– Consultants
– Others Interested in Trade

Eligible for 1 CCS/MCS NEI Credit
– Input your NCBFAA NEI ID number at the time of registration to receive credit

Importing Medical Devices in Compliance With U.S. FDA

Jennifer Diaz — Wed, 25 Aug 2021 17:56:09 +0000

This one-hour webinar provides an overview of FDA regulations and requirements for imports of medical devices. Presenters will discuss how FDA defines and regulates a medical device, as well as what requirements FDA imposes when importing a medical device

The Presentation Will Cover the Pathway to Legally Market a Medical Device in the US, Including:
– How to Determine if Your Product is a Medical Device
– How to Find Your “Product Code” and Device Class
– How to Determine the Requirements to Import Your Device Class Into the U.S.
– How to Register a Medical Device With the FDA
– Who Needs a U.S. Agent
– How to Perform Due Diligence on Your Manufacturer Registration and Listing Information
– What Premarket Submissions are Required for Specific Products
– Labeling Requirements (Including UDI) when Importing Medical Devices
– “Top 10 Tips When Importing Medical Devices”
– Best practices for Responding to Enforcement Actions

Presenters:
– Jennifer Diaz
– Denise Calle

Who Should Attend:
– Importers
– Customs Brokers
– Regulatory Affairs Professionals
– In-house Legal Counsel
– Product Development Managers
– Consultants
– Others Interested in FDA

Eligible for 1 CCS/MCS NEI Credit
– Input your NCBFAA NEI ID number at the time of registration to receive credit

FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions

Jennifer Diaz — Wed, 09 Jun 2021 17:29:25 +0000

This one-hour webinar provides an overview of FDA regulatory enforcement actions. You will learn about FDA regulations and laws pertaining to over-the-counter (OTC) drugs and cosmetics marketed in the United States. The presentation will discuss real scenarios, including labeling dos and don’ts. The objective of the webinar is to teach manufacturers, importers, and the like, how to navigate FDA’s regulatory framework, provide TOP compliance tips to avoid FDA enforcement actions, and strategies when you are faced with an enforcement action.

In This Webinar You Will Learn:
– How FDA Regulates OTC Drug and Cosmetic Products (and How to Differentiate Your Product)
– Labeling Dos and Don’ts (Including a Discussion on Intended use)
– Top Tips for Compliance
– Types of FDA Enforcement Actions
– Best Practices for Responding to Enforcement Actions (Including Real Life Examples)

Presenters:
– Jennifer Diaz
– Denise Calle

Who Should Attend:
– Importers
– Customs Brokers
– Regulatory Affairs Professionals
– In-house Legal Counsel
– Product Development Managers
– Others Interested in FDA

Eligible for 1 CCS/MCS/CES/MES NEI Credit
– Input your NCBFAA NEI ID number at the time of registration to receive credit