Speakers

Ronda A. Balham, OD, Consultant, Becker & Associates Consulting, Inc.
Keith A. Barritt, Principal, Fish & Richardson, PC
Melissa B. Burns, Biomedical Engineer, CDRH, FDA
David B. Clissold, Director,  Hyman, Phelps & McNamara, P.C.
Danica Dabic-Marinac, MD, PhD, Chief of Epidemiology, Division of Postmarket Surveillance, Office of Surveillance & Biometrics, CDRH, FDA
Alan G. Minsk, Partner & Leader, Food & Drug Practice Group, Arnall Golden Gregory, LLP
Larry R. Pilot, Partner, McKenna Long & Aldridge, L.L.P.
Rene Y. Quashie, Senior Associate, Drinker Biddle & Reath, LLP
Patricia B. Shrader, Senior Vice President, Regulatory and External Affairs, BD
Lauren R. Silvis, Attorney, Sidley Austin, LLP

Program Description

Through a blend of presentations and active learning opportunities, you will learn the essential elements of medical device regulations in a systematic and comprehensive way.  The first day will focus on the legal framework, FDA’s organization and premarket requirements; the second day will focus on postmarket requirements, Quality System Regulation (QSR), adverse events, and promotion and advertising.  The program will walk you through key regulations and policies while it helps you develop a clearer understanding of how they work.  You’ll receive an overview of the FDA regulatory structure, obtain pointers on how to prepare a successful 510(k) submission, and learn about new and developing FDA policies and procedures affecting all phases of medical device regulation.  This program will help you to think like a seasoned medical device professional.  Additionally, you will learn how FDA enforces the laws passed by Congress and some of the “hot” issues of the day, including how the Food and Drug Administration Amendments Act of 2007 (FDAA Act) will impact your medical device organization This meeting can help you and your organization stay in compliance with FDA regulations, get products approved, and help minimize regulatory problems.

Who Should Attend
Regulatory and clinical affairs, research and development, quality control professionals
New senior managers of small medical device companies
New associates in law firms and product liability lawyers
Personnel in legal departments at medical device companies

This is also a good refresher meeting for seasoned regulatory affairs and legal professionals. Continuing Legal Education credits are available after attending this program.

This program will promote an informal, classroom atmosphere where dialogue and questions will be encouraged.  FDLI suggests that attendees dress comfortably, i.e., “casual business attire.”

Attendee Handouts
FDLI’s Statutory Supplement: Federal Food, Drug, and Cosmetic Act including the FDA Amendments Act of 2007 and Related Sections of Additional Statutes
Binder of speaker handout materials

Continuing Legal Education (CLE) Credits
Pending state approvals, CLEs will be awarded.

CLEs to be awarded from the following states:
Pennsylvania 13.00
New York 13.00
Ohio 12.75

CLEs will be published as we gain state approval

Registration Fees
Early Bird Rate (Received before Sunday, October 5, 2008)
$920 FDLI Members
$1,345 Non-members
$745 Academics, 501(c)(3) Nonprofit, Government

Standard Rate (Received after Sunday, October 5, 2008)
$1,020 FDLI Members
$1,420 Non-members
$820 Academics, 501(c)(3) Nonprofit, Government

Special CD Price!
Purchase the CD set for just $99 with your registration. To receive the special price, CDs must be purchased at the time of registration. Offer limited to one CD set per registrant. In order to use this CD, your portable CD player or computer player must be able to support the MP3 format. Shipping & handling charges will apply.

Tax: CD orders shipped to Washington, DC addresses will be charged 5.75% sales tax. Orders to Maryland addresses will be charged 6% sales tax.

Please contact FDLI at (800) 956-6293 or (202) 371-1420, or e-mail comments@fdli.org.

Conference Registration Policy

November 6
View the agenda for Day Two

8 AM
Registration and Continental Breakfast

FDLI Welcome and Announcements

Overview of Medical Device Law and Regulation; What You Will Learn

1. Sources of Law
   1. Statutes
      1. Federal Food, Drug and Cosmetic Act of 1938 (FDCA)
      2. Radiation Control for Health and Safety Act of 1968 (RCHS)
      3. 1976 Medical Device Amendments
      4. Safe Medical Devices Act of 1990 (SMDA)
      5. Mammography Quality Standards Act of 1992 (MQSA)
      6. Food and Drug Administration Modernization Act of 1997 (FDAMA)
      7. Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
         i.          User Fees
         ii.         Reprocessed Single-Use Devices
      8. Medical Device User Fee Stabilization Act of 2005 (MDUFSA)
      9. The Food and Drug Administration Amendments Act of 2007 (FDAA Act)
   2. Regulations (21 CFR § 801 et seq.)
   3. Guidance Documents, Other Policy Pronouncements, Enforcement Actions
   4. Internet/Web Access
2. Regulation as a Medical Device
   1. Definition of “Medical Device”
      1. Determining if a Product is a Medical Device; Section 513(g) Process and pre-IDE Meetings
      2. Software-based Diagnostic Products
   2. Combination Products
      1. CDRH-CDER Intracenter Agreement
      2. Designation Requests
      3. Office of Combination Products
      4. Primary Mode of Action (PMOA)
   3. Device Classification
      
      1. Definitions of Class I, II, III
         
      2. Examples
      3. General and Special Controls
3. General Nature of Requirements and Restrictions
   1. Product Testing
      1. Preclinical Testing
      2. Clinical Trials
   2. Access to Market
      1. Premarket Notification (510(k)
      2. Premarket Approval Application (PMA)
   3. Manufacturing
   4. Marketing/Promotion
   5. Reporting
4. Accessing Information
   1. Confidentiality
   2. Freedom of Information Act (FOIA)

FDA Organizational Structure


1. U.S. Department of Health and Human Services, Food and Drug Administration,CDRH
   1. Office of the Center Director
      1. Director
      2. Ombudsman
   2. Office of Device Evaluation (ODE)
   3. Office of Compliance
      1. Division of Bioresearch Monitoring (DBM)
      2. Promotion and Advertising Staff
   4. Division of Small Manufacturers, International and Consumer Assistance
   5. Office of In Vitro Diagnostic Device Evaluation and Safety
      1. Clinical Laboratory Improvement Amendments of 1988 (CLIA)
         and Waiver Applications
   6. Office of Science and Engineering Laboratories
   7. Office of Surveillance and Biometrics
2. FDA’s Office of Regulatory Affairs (ORA)
3. FDA’s District Offices
4. Office of the Chief Counsel (OCC); U.S. Department of Justice, Office of Consumer Litigation – FDA’s Attorney’s
5. Working with FDA; How to/When to Communicate with FDA
   

Refreshment Break

Premarket Notification (510(k))

1. Overview
2. Exemptions
3. Content of a 510(k) Submission
   1. Traditional 510(k)
   2. Abbreviated 510(k)
   3. Special 510(k)
4. Substantial Equivalence
   1. Statutory Definition
   2. Predicate Devices
5. FDA Consideration and Review
   1. Refusal to Accept
   2. FDA Actions
      1. Substantially Equivalent (SE)
      2. Not Substantially Equivalent (NSE)
   3. De Novo Review
   4. Other Issues
      1. General/Specific Intended Use
      2. Special Controls
6. Modifications to a Cleared Device
7. Use of Standards
8. Third Party Review
9. User Fees
10. Proprietary Information
    
11. Case Study Attendees assess situations where a 510(k) may or may not be necessary and think about the information that should be submitted in a 510(k).

12:00 PM-1:15 PM
Lunch

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Registration and Listing

1. Who Must Register/List
2. How to Register/List
3. When to Register/List
4. Updates to Device Listing
5. U.S. Agents
6. Exemptions

Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRB’s) and Informed Consent

1. Overview
2. “Significant Risk” Devices
3. Abbreviated Requirements
4. Exemptions
5. Commercialization
6. Treatment IDEs
7. In Vitro Diagnostic (IVD) Devices
   1. Definition and Labeling Requirements
   2. Investigational Use Only
   3. Research Use Only
8. Submitting an IDE
   1. Contents of an IDE Application
   2. IDE Supplements
9. FDA Actions
10. IDE Amendments
11. Institutional Review Board (IRB)
    1. Composition
    2. Operations
    3. Records
    4. Reports
12. Informed Consent
    1. Required Elements
    2. Additional Elements
    3. Waivers
    4. Emergency Use

Refreshment Break

Clinical Investigations: Sponsor Responsibilities and Compliance Issues


1. Responsibilities of Clinical Trial Sponsor
2. Clinical Investigator’s Responsibilities
3. Good Clinical Practices (GCPs) and Good Laboratory Practices (GCPs)
4. Bioresearch Monitoring (BIMO)
5. Investigator Restriction/Disqualification
6. Recent Enforcement Actions
7. Adverse Event Reporting (AER)
8. Ethical Issues
   1. IRB Actions
   2. Incentives for Enrollment
   3. Patient Population
      

Premarket Approval Application (PMA)

1. Purpose
2. Content of a PMA
   1. Application Requirements
   2. Clinical Data
   3. Financial Disclosure
   4. “Least Burdensome” Approach
3. PMA Approval Process
   1. Refusal to File
   2. Expedited Review
   3. 100-Day Meeting
   4. Dispute Resolution
4. PMA Amendments
5. Advisory Panels
   1. Role of Panel
   2. Meeting Procedures
6. Recent Developments
   1. Modular PMA
   2. Real Time Review of PMA Supplements
   3. PMA Supplements for Manufacturing Changes
   4. Meetings with FDA
7. Product Development Protocols (PDPs)
8. Device Master Files; Component Suppliers
9. Humanitarian Device Exemption (HDE)

5:00 PM
Adjournment for the Day

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November 7
View the agenda for Day One

8 AM
Continental Breakfast

FDLI Announcements

Post Marketing Issues

1. Ongoing Monitoring of Device Performance
   1. Conditions of PMA Approval/510(k) Clearance
   2. Statutory Programs
      1. Device Tracking
      2. Post Market Surveillance
   3. Company-initiated Investigations
2. Adverse Events/Product Problems
   1. Complaint Handling and Investigation
   2. Medical Device Reporting (MDR); Physician-directed Communications
      1. Purpose
      2. Definitions
      3. Requirements
      4. Reporting Forms
      5. Examples
3. Product Recalls
4. Report of Corrections and Removals
5. Reprocessing of Single-Use Devices

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Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)

1. FDA Approval /Clearance
   1. 510(k)
   2. IDE/PMA
   3. Reimbursement Implications:
   1. Healthcare Common Procedure Coding System (HCPCS) Product Codes and Picking the Predicate Device
   2. Coverage of Category B - IDE Devices
2. Safety and Effectiveness ≠ Reasonable and Necessary
   
   1. Medicare Coverage Requirements – Data Showing Improved Health Outcomes, Significant Clinical Advantages
   2. Examples of Recent Coverage Decisions
   3. New Technology Diagnosis-Related Group (DRG) Add On and New Device Pass Through
3. Distinguishing FDA Data Needs from CMS Data Needs
   1. Patient Selection Criteria for Clinical Trials – over 65
   2. Clinical End Points – Non-Inferiority ≠Superior Clinical Benefits
   3. Proof of Long Term Efficacy – Post Marketing Studies
4. CMS’ New Policy on Coverage for Clinical Trials and Research, and CLIA Waiver Designations
5. Practical Tips to Link FDA with Reimbursement
   1. Selecting the Route for Approval/Clearance
   2. Picking the Predicate Device
   3. Structuring Clinical Trial
   4. Labeling to Support Coverage and Reimbursement

Refreshment Break

Quality System Regulation (QSR)

1. History, Purpose, and Scope
   
2. Changes from Prior Good Manufacturing Practices (GMPs)
3. Regulatory Requirements
   
4. Quality System Inspection Technique (QSIT)
   1. Management Controls
   1. Design Control
   2. Production and Process Controls
   3. Corrective and Preventive Action (CAPA)
5. Integration of QSR Systems

11:45 AM-1 PM
Lunch

Promotion and Advertising

1. Scope of FDA Authority; Promotion and Advertising Policy Staff, Office of Compliance, CDRH
   1. “Label” and “Labeling”
   2. Advertising
2. “False or Misleading”; Misbranding
3. Federal Trade Commission (FTC) Regulation
4. Unapproved Devices
5. Off-label Use
6. Labeling/Promotion Issues
7. Claim Substantiation
   1. Generally
   2. Comparative Claims
   3. “Establishment” Claims
8. Direct-to-Consumer (DTC) Advertising
   1. Restricted Devices
   2. OTC Devices
   3. DTC Guidance; Consumer-Directed Promotion of Regulated Medical Products
9. First Amendment Issues
   1. Washington Legal Foundation v. Henney
10. Monitoring Compliance
    1. Tradeshows
    2. Scientific Forums
    3. Detailers
    4. Internet
    5. Remuneration
11. Recent Enforcement Actions, Trends
    1. False Claims Act and Qui tam Actions
    2. Anti-Kickbacks
       

Hypothetical/Case Study
Working in small groups and using knowledge obtained during the workshop participants will identify and address regulatory issues in the course of a problem-solving exercise.

Refreshment Break

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Enforcement and Compliance

1. FDA Inspections
   1. Scope of Authority
   2. Usual Techniques/Procedure
   3. Inspection Tips
2. Prohibited Acts
   1. Adulteration
   2. Misbranding
   3. Unapproved Device
   4. General Purpose Laws under Other Statutes
   5. Interstate Commerce
3. Enforcement Tools
   1. Warning Letters (WLs)
   2. Product Seizure
   3. Injunction
   4. Civil Penalties
   5. Disgorgement
   6. Criminal Liability
   7. Import Alerts
4. Other Enforcement Authorities; Communicating and Responding
   1. Office of the Inspector General (OIG)
   2. U.S. Department of Justice (DOJ)
      1. FDA’s lawyers - Office of Consumer Litigation
      2. U.S. Attorneys
   3. The Securities and Exchange Commission (SEC)
   4. Federal Trade Commission (FTC)
   5. The States; State Attorneys General

International Issues


1. Legal Framework
   1. FDCA, Chapter VIII, Sections 801 and 802
   2. Food and Drug Export Reform and Enhancement Act of 1996 (FDERA)
   3. Electronic Product Radiation Control
2. Exports
   1. Approved Devices
   2. Unapproved Devices
   3. Investigational Devices
   4. Adulterated or Misbranded Devices
   5. Notification
   6. Recordkeeping
   7. Certificate of Exportability (COE); Certification for Foreign Government (CFG)
3. Imports
   1. Roles of FDA and Customs and Border Protection (CBP); Inspections
   2. Grounds for Refusing Admission
      1. Detentions
   3. “Application for Authorization to Relabel and Recondition”
      1. Conditions are Fulfilled = Product is Released
      2. Conditions are not Fulfilled/Device Still Appears to be in
         Violation = Destroyed or Exported
   4. Import for Export
4. European Union (EU) Directives
   1. CE Mark Process; Notified Bodies
   2. Quality Systems Regulation, Mutual Recognition Agreement, Conformity Assessment Bodies

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5:00 PM
Conclusion