Course Description:

The FDA regulates medical devices marketed and sold in the U.S. on the basis of potential risk and according to a three category classification system.

This course on the U.S. Food and Drug Administration's 510(k) clearance and premarket approval process is intended to provide attendees with an introduction to the U.S. FDA regulation of medical devices. It will cover the FDA and its regulatory authority as it relates to medical devices. The presenter will discuss the FDA’s medical device classification system and offer suggestions for determining how a particular device will be classified and regulated. The process for going to market with a Class I, Class II and Class III device will be described with particular attention being paid to the preparation and submission of 510(k)s and PMAs.

This seminar will also provide an overview of a medical device manufacturer’s and/or distributor’s regulatory responsibilities as well as issues related to the FDA’s requirements governing medical device manufacturing, labeling and user fees. It will cover strategies for preparing and surviving the FDA on-site inspection. Finally, an overview of FDA’s medical device-focused enforcement activities and methods for mitigating enforcement risks will be discussed.

Learning Objective:

Upon completing this course on FDA regulation of medical devices, participants will:

  • Gain a basic understanding of the FDA’s structure and its laws and regulations applicable to medical devices.
  • Develop a familiarity with the FDA’s Medical Device Classification System and learn the difference between Class I, Class II and Class III medical devices.
  • Understand the difference between a 510(k) and a PMA, and when each is required.
  • Learn what is included in a 510(k), how to prepare a 510(k) and the process for selecting a predicate device.
  • Develop a basic understanding of the FDA’s Quality System Regulation (21 CFR Part 820).
  • Learn what is involved in an FDA inspection, how to prepare for an FDA inspection and strategies for undergoing a successful inspection.
  • Become familiar with the FDA’s various enforcement options as they relate to medical device marketing and sales

Who will Benefit:

This course is designed for people tasked with developing a regulatory and business strategy for the marketing and sale of medical devices in the United States. This includes individuals who are responsible for ensuring medical device compliance with the FDA’s regulatory requirements and obtaining the relevant clearance or approval needed to market and sell such products, and those tasked with the shipping and export of medical devices to the U.S. The following personnel will benefit from the course:

  • Medical Device Manufacturers
  • Senior Regulatory Professionals
  • Compliance Professionals
  • Medical Device Designers / Design Engineers
  • Corporate Legal Departments
  • Medical Device Exporters and Importers
  • Regulatory Consultants
  • Research Analysts
  • Production Supervisors
  • Quality Control Personnel
  • Medical Affairs
  • Regulatory Auditors
  • Customs Brokers
  • Medical Device Labelers
  • Convenience Kit Manufacturers
  • State Policy Officials
  • Investment Analysts
  • Venture Capitalists
  • M&A Professionals

Topic Background:

The FDA regulates medical devices marketed and sold in the U.S. on the basis of potential risk and according to a 3 category classification system. Class I medical devices are deemed to be low risk and possess the lowest regulatory threshold for entry into the market. Class II medical devices are deemed to present an intermediate risk to the user and requires the submission of a 510(k) Premarket Notification establishing substantial equivalence to a selected predicate device. Finally, Class III devices are considered novel and unique, and are deemed to pose a higher level of risk than the other device categories. Class III devices require FDA Premarket Approval prior to marketing and sale.

Course Outline:

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

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. An overview of FDA and its statutory requirements
  2. The Medical Device Regulations
    1. Breaking down FDA’s Medical Device Regulations and what they cover
  3. The Medical Device Classification System
    1. Different classes of medical devices
    2. Examples of each class
    3. General v. Specific controls
  4. Determining the regulatory status of a proposed medical device
  5. Class I Medical Devices
    1. What are they?
    2. Examples
    3. Regulatory requirements
    4. Marketing Class I in the U.S.
  6. Class II Devices and the 510(k) Premarket Notification
    1. What are they?
    2. Examples
    3. The elements of a 510(k) Premarket Notification
    4. Identifying an appropriate predicate device
    5. What device-related information is required
    6. What types of testing is required?
    7. Drafting and filing a 510(k) notification
    8. Timing Rules and the “180-day clock”
    9. Receipt of FDA questions and how to respond
    10. Obtaining 510(k) Clearance
    11. Marketing Class II Devices in the U.S.
  7. Class III Devices and Pursuing Premarket Approval
    1. What are they?
    2. Examples
    3. Introduction to the Medical Device Pre-Market Approval Program
    4. The elements of a PMAs
    5. The types of product information and testing required
    6. Drafting, Assembling and Filing a PMA
  8. The Process for bringing a medical device to market in the U.S.
  9. Individual Device Exception (“IDE”)
  10. User Fees and the Small Business Waiver Program

  1. An Introduction to the Quality System Regulation (21 CFR Part 820)
    1. What is the QSR?
    2. The purpose of the QSR
    3. Where to find it in the regulations
    4. What does it cover?
    5. Establishing a quality management system
    6. Global Harmonization
  2. A Manufacturer’s Other Responsibilities
    1. Registration
    2. Listing
    3. Adverse Event Reporting
  3. Contract Manufacturing
    1. Definition
    2. Registration Rule
  4. Labeling and Promotion
    1. The rules governing marketing and promotion
    2. The use of published literature and scientific studies in marketing materials
    3. Off-label promotion
    4. Examples of non-compliant promotion
    5. Strategies for avoiding FDA enforcement action
  5. Facility Inspections
    1. FDA’s inspectional authority
    2. Notice of inspection
    3. How to prepare for a facility inspection
    4. Conducting a mock audit
    5. The FDA inspector
    6. The day of the inspection
    7. Examples of inspections gone wrong
  6. The Status of the Medical Device Excise Tax
    1. What is it?
    2. What is the status of the tax?
  7. Overview of FDA’s Current Regulation of Mobile Medical Devices and Medical Apps
    1. What is a mobile medical device?
    2. What is a medical app?
    3. Examples
    4. How is FDA regulating them?
    5. FDA’s 2013 final guidance documents
  8. Exporting Medical Device Samples to the U.S. for Trade Shows
    1. What is required to comply with FDA rules
  9. Import for Export Rules
  10. General Export Issues
    1. FDA’s requirements for export
    2. What product information is required?
    3. The U.S. Port System
    4. FDA Port Inspectors
    5. Introduction to Customs and Border Patrol and their role
    6. Product labeling and sampling
    7. Product “holds”, “detentions” and “quarantine”
    8. Import alerts
    9. Securing removal from an import alert
  11. Case Studies: Exercises Designed To Put the Course Material to Practice

Meet Your Instructor

Karl M. Nobert
Food and Drug Regulatory Attorney, The Nobert Group LLC

Karl M. Nobert is a food and drug regulatory attorney with the Nobert Group LLC. Mr. Nobert provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. This includes counseling clients on FDA’s regulation of prescription branded and generic drugs, and over-the-counter drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products. He frequently presents and has published on such topics.

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