become a member

An Introduction to the Regulation of Combination Products for Medical Devices

Recognize what comprises combination and non-combination products. Understand the role of the Office of Combination Products (OCP) and how products are assigned to FDA’s medical product centers.

Nicholas M. Benetatos, Principal, Exponent, Inc.

This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in October 2024.

Get Access

$199

+$100 for nonmembers

Virtual Learning FAQ

When will I receive my session?

On-demand webinar content is sent via email as soon as we are able to process and verify your order. This usually occurs within 1 business day.

Is my computer/mobile device compatible?

On-demand content can be played back on most devices.

Is CLE credit available?

CLE credit is not currently available for pre-recorded sessions.

Related Content

The Results Are In: How the 2024 Election Outcomes Will Impact Healthcare Policies

An Introduction to Drug Enforcement: FDA Enforcement Authorities, Tools, Violations and Initiatives

Regulation of Drug Marketing: An Introduction

Regulation of Drug Manufacturing: An Introduction

Regulation of Over-the-Counter (OTC) Drugs: An Introduction

The Regulation of Biologics and Biosimilars: An Introduction

Post Approval Requirements for Drugs: An Introduction to Safety Reporting and Post-Approval Changes

An Introduction to the Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues

The New Drug Approval Process: NDA Submission and Review

The New Drug Approval Process: New Drug Research and Development

The New Drug Approval Process: Basic Concepts

Origins and Overview of Drug Law Regulation: An Introduction

International Issues for Medical Device Manufacturers: An Introduction

An Introduction to the Regulation of Promotion and Advertising for Medical Devices

FDA Authorities and Processes for the Enforcement, Compliance, and Inspection of Medical Devices

Regulatory Requirements for Medical Device Manufacturing and Quality System (QS) Regulation: An Introduction

Post Marketing Issues for Medical Devices: An Introduction

An Introduction to Coverage, Coding, and Payment of Medical Devices – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)

Medical Device Premarket Approval Applications (PMA); Humanitarian Device Exemption (HDE) and Breakthrough Devices: An Introduction

An Introduction to the Medical Device Approval Process: Premarket Notification 510(k) and De Novo Requests

Medical Device Clinical Investigations: An Introduction

Regulation of Digital Health Products: An Introduction

An Introduction to the Regulation of Combination Products for Medical Devices

Overview of Medical Device Law and Regulation

Case Studies/Hypotheticals for an Introduction to Medical Product Advertising and Promotion

An Introduction to Multi-Channel, Pre-Approval, and Non-Promotional Communication

An Introduction to Other Agencies and Considerations Involved in Medical Product Advertising and Promotion

An Introduction to Dissemination of Information about Unapproved Uses for Medical Product Advertising and Promotion

An Introduction to Applicable FDA Offices, Essential Principles, & Key Definitions for Medical Product Advertising and Promotion

FDA Inspections and Enforcement: Tobacco and Nicotine Product Manufacturers and Retailers

Tobacco and Nicotine Product Compliance

The Public Heath Standard for Tobacco and Nicotine Products

Pathways to Market for Tobacco and Nicotine Products

United States Tobacco and Nicotine Product Regulation: The Family Smoking Prevention and Tobacco Control Act (TCA) and the Deeming Regulation

Advancing the Mission: Former FDA Chief Counsels on FDLI’s Future as a Resource for the Bar

Food and Dietary Supplement Imports and International Issues: An Introduction

FDA Inspection and Enforcement Authority for Food and Dietary Supplement Manufacturers

Food Advertising: An Introduction to the Federal Trade Commission and Private Rights of Action

Food Labeling: An Introduction to Nutrient Content, Health, and Other Claims

Food Labeling: An Introduction to General Requirements (Including Meat and Poultry)

The Regulation of Dietary Supplements: An Introduction

Foods Developed Using Biotechnology and Animal Cell Culture Technology – US Regulatory Oversight

An Introduction to U.S. Department of Agriculture Labeling, Inspection and Ingredient Approval Requirements

Food Safety: Current Good Manufacturing Practices and Related Requirements; Unintended Components/Contaminants of Food

Food Safety: An Introduction to Ingredient Preclearance/Intentional Components of Food

The Regulation of Cosmetics: An Introduction

Overview of U.S. Food Law and Regulation: An Introduction

The Fate of FDA Authority: Addressing Recent Supreme Court Decisions on Mifepristone, Chevron, and Beyond

Decoding FDA’s New Rule on LDTs: Insights, Implications, and Legislative Considerations

Veterinary Products Caselaw and Emerging Trends: An Introduction

An Introduction to Animal Food, Feed, and Supplements Requirements and Challenges

An Introduction to Veterinary Drug and Device Requirements and Challenges

Veterinary Product Regulation: An Introduction to the Roles and Responsibilities of FDA and USDA

Veterinary Products: An Introduction to the Federal Regulatory Landscape

An Introduction to Laws Governing Veterinary Products

An Introduction to Violations, Enforcement, and International Issues in Biologics and Biosimilars

The Regulation of Biological Product Marketing: An Introduction

The Regulation of Biological Product Manufacturing: An Introduction

Post-Approval Pharmacovigilance of Biological Products: An Introduction

Biologics and Biosimilars: An Introduction

Biological Product Approval, Vaccines, Emergency Use Authorization: An Introduction

Introduction to Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy

Regulation of Biological Product/Drug Development: An Introduction

Introduction to FDA Review and Approval of Biological Products

Overview of Biological Products Law and FDA’s Regulatory Processes

USPTO-FDA Collaboration: Progress Towards Patently True Interagency Coordination

Enhancing Engagement Opportunities and Communication with FDA

Collaboration Across Agencies: Understanding the Role of FDA, USDA, and EPA in Food Regulation

Fundamentals of FDA Regulation of Cosmetics

FDLI Book Launch—How FDA Really Works: Insights from the Experts

Supply Chain Mayhem: Industry Impacts and What Can be Done

Essentials of Post-Inspection Actions: From FDA Notices to Criminal Prosecution

Essentials of Inspection Readiness for Medical Products

Essentials of FDA, DOJ, FTC Enforcement Authorities

You Can’t Outsource Responsibility: Managing Quality in a Contract Manufacturing Partnership

Over-the-Counter Drugs Monograph Reform – How’s it Going?

FDA’s COVID-19 Activities

The Promise and Problem of Blockchain for Medical Products: What Lawyers Need to Know

Navigating the Complexities of Combination Product Regulation

Medical Device Clinical Investigations: An Introduction to Sponsor Responsibilities and Compliance Issues

Medical Device Manufacturer Requirements: An Introduction to Registration and Listing of Establishments

FDA and Centers for Medicare and Medicaid Services: Regulatory Considerations for Communicating and Contracting for Value

Best Practices for Drug Recalls

The Essentials of Food Science

Machine Learning for Regulatory Attorneys and English Majors

The Essentials of Tobacco and Nicotine Product Research

The Essentials of Statistics for Medical Products Lawyers

The Essentials of Clinical Trial Science

The Impact of COVID-19 on the In Vitro Diagnostic Industry

FDA’s Legal Authority Over Laboratory Developed Tests

State of FDA Medical Product Manufacturer Inspections During and After COVID-19

Restarting Clinical Trials in the Wake of COVID-19

COVID-19 and Beyond: Development and Implementation of Recovery Action Plans for Medical Product Manufacturers

FDA’s Recent COVID-19 Guidances Facilitating Expanded Access to Certain Medical Products

What are FDA’s Tools for Responding to Public Health Emergencies Such as the Coronavirus (COVID-19)?

FDA-Related Congressional Committees: Jurisdiction, Focus, and Roles

Nicotine: What it Is, What it Does, and How to Effectively Communicate this Information to the Public

A Practical Guide to Bringing a Dietary Supplement to Market

Reducing Anti-Kickback Risks Associated with Medical Products

Introduction to the Regulation of Cannabis-Derived Products

Introduction to Product Liability Regarding FDA-Regulated Products

Due Diligence: Ensuring Your Deal Doesn’t Collapse Due to Regulatory, Clinical, Quality, or Data Integrity Issues

From Approval to Coverage – FDA and CMS Jurisdictional Lines

Drug Pricing for the Food and Drug Community

Organic Chemistry for the Food and Drug Community

DEA Law for the Food and Drug Community

New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century Cures

Development of Medical Devices: Best Practices for Safeguarding Your IP and FDA Rights

FDA, USDA, and EPA: Inter-Agency Overlap and Jurisdictional Boundaries

The EU’s New Medical Device and IVD Regulations

Recent FDA Guidance Documents on Manufacturer Communications about Medical Products

21st Century Cures Act

Hannah Brown2024-11-20T15:43:48-05:00