Speakers
Ronda A. Balham, OD, Vice President, Healthcare Research Group, Marwood Group
Martin Browning, President, EduQuest, Inc
Jeffrey N. Gibbs, Principal, Hyman, Phelps & McNamara, P.C.
Robert J. Klepinski, Attorney, Fredrikson & Byron, P.A.
Laura E. Loeb, Partner, King & Spalding, LLP
Judith K. Meritz, Shareholder, Baker, Donelson, Bearman, Caldwell & Berkowitz, PC
Alan G. Minsk, Partner, Arnall Golden Gregory LLP
Neil F. O'Flaherty, Principal, Olsson Frank Weeda Terman Bode Matz P.C.
Caryn Silverman, Partner, Sedgwick Detert Moran & Arnold LLP
Keisha R. Thomas, MHS, Consumer Safety Officer, Office of Compliance, CDRH, FDA

Program Description
In this interactive two-day program, 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 pre-market requirements and the second day will focus on postmarket requirements, the 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.  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

A binder of speaker handouts

FDLI's FDCA Statutory Supplement, including the FDA Amendments Act and Related Sections of Additional Statutes

Continuing Legal Education (CLE) Credits
CLEs have been approved from the following state(s):

Pennsylvania = 13 credits
Virginia = 13 credits

Registration Fees
Early Bird Rate (Received before Monday, October 19, 2009)
$945 Member
$1,370 Non-member
$770 Academics & Government

Regular Rate (Received after Monday, October 19, 2009)
$1,045 Member
$1,445 Non-member
$845 Academics & 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 and Maryland addresses will be charged 6% sales tax.

Please contact Customer Service at (800) 956-6293 or (202) 371-1420,
or by e-mail at CSDept@fdli.org, if you have any questions about your conference registration or CD order.

November 17
Go to agenda for day two >

8:00 a.m.                     
Registration and Continental Breakfast

8:30 a.m.
FDLI Welcome and Announcements

8:45 a.m.
I. Overview of Medical Device Law and Regulation; What You Will Learn
            A.Sources of Law
                        1. Statutes
                        2. Regulations (21 CFR § 801 et seq.)
                        3. Guidance Documents, Other Policy Pronouncements,
                            Enforcement Actions
                        4. Internet/Web Access
            B. Regulation as a Medical Device                               
                        1. Definition of “Device”
                        2. Device Classification
                        3. Combination Products
            C. General Nature of Requirements and Restrictions
                        1. Product Testing           
                        2. Access to Market
                        3. Manufacturing
                        4. Marketing/Promotion
                        5. Reporting
            D. Accessing Information
                        1. Confidentiality
                        2. Freedom of Information Act (FOIA)
            E. Electronic Products

II. FDA Organizational Structure
            A. U.S. Department of Health and Human Services, Food and Drug
                Administration, CDRH
                        1. Office of the Center Director
                        2. Office of Device Evaluation (ODE)
                        3. Office of In Vitro Diagnostic Device Evaluation and Safety       
                        4. Office of Compliance
                        5. Office of Surveillance and Biometrics
                        6. Office of Science and Engineering Laboratories
                        7. Division of Small Manufacturers, International and
                            Consumer Assistance
            B. FDA’s Office of Regulatory Affairs (ORA)
                        1. Office of Criminal Investigation (OCI)          
            C. FDA’s District Offices
            D. Office of the Chief Counsel (OCC); U.S. Department of Justice,
                Office of Consumer Litigation – FDA’s Attorney’s
            E. Working with FDA; How to/When to Communicate with FDA

Refreshment Break

III.       Premarket Notification (510(k))
            A. Overview
            B. Exemptions
                        1. Class 1 & 2 Exempt Status and Limitations
                        2. Pre-amendment
            C. Content of a 510(k) Submission
                        1. Traditional 510(k)
                        2. Abbreviated 510(k)
                        3. Special 510(k)
            D. Substantial Equivalence
                        1. Statutory Definition
                        2. Predicate Devices
            E. FDA Consideration and Review
                        1. Refusal to Accept
                        2. FDA Actions
                        3. De Novo Review
                        4. Other Issues
            F. Use of Standards
            G. Third Party Review
            H. User Fees
            I. Modifications to a Cleared Device
            J. Case Study
                Attendees assess situations through which a 510(k) may or may not be
                necessary and think about the information that should be submitted
                in a 510(k).

12 Noon-1:15 p.m.     
Lunch

•• Back to Top

1:15 p.m.
IV. Registration and Listing                                
            A. Who Must Register/List
            B. How to Register/List
            C. When to Register/List
            D. Updates to Registration/Listing
            E. U.S. Agents
            F. Exemptions

V.Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRB’s) and Informed Consent
            A. Overview
            B. ‘Significant risk’ vs. ‘Non-Significant Risk’ Devices
            C. Submitting an IDE
                        1. Contents of an IDE Application
                        2. Amendments
            D. Actions
            E. Supplements                                        
            F. Abbreviated Requirements
            G. Supplements    
            H. Institutional Review Board (IRB)
                        1. Composition
                        2. Operations
                        3. Records
                        4. Reports
            I. Treatment IDEs
            J. Informed Consent
                        1. Required Elements
                        2. Additional Elements
                        3. Waivers
                        4. Emergency Use
            K. Exemptions
                        1. Promotion/Commercialization Including Solicitation

Refreshment Break

VI. Clinical Investigations: Sponsor Responsibilities and Compliance Issues
            A. Responsibilities of Clinical Trial Sponsor
                        1. Including Financial Disclosure Requirements
            B. Clinical Investigator’s Responsibilities
            C. Adverse Event Reporting (AER)
            D. Bioresearch Monitoring (BIMO)
            E. Investigator Restriction/Disqualification
            F. Recent Enforcement Actions
            G. Ethical Issues
                        1. IRB Actions
                        2. Incentives for Enrollment
                        3. Patient Population

VII. Premarket Approval Application (PMA)
            A. Purpose
            B. Content of a PMA
                        1. Application Requirements
                        2. Clinical Data
                        3. Financial Disclosure
                        4. “Least Burdensome” Approach
                        5. Modular PMA
            C. PMA Approval Process
                        1. Refusal to File
                        2. Expedited Review
                        3. 100-Day Meeting
                        4. Dispute Resolution
            D. PMA Amendments
            E. PMA Supplements
            F. Meetings with FDA
            G. Advisory Panels
                        1. Role of Panel
                        2. Meeting Procedures
            H. Device Master Files; Component Suppliers
            I. Humanitarian Device Exemption (HDE)

5:00 p.m.                     
Adjournment for the Day

•• Back to Top

November 18
Back to agenda for day one >

8:00 a.m.                     
Continental Breakfast

8:30 a.m.                     
FDLI Announcements

VIII. Post Marketing Issues                    
            A. Adverse Events/Product Problems                                
                        1. Complaint Handling
                        2. Medical Device Reporting (MDR)
            B. Product Recalls
            C. Reports of Corrections and Removals
            D. Safety Alerts & Physician Communication
            E. Ongoing Monitoring of Device Performance                                         
                        1. Conditions of PMA Approval/510(k) Clearance
                        2. Statutory Programs

Refreshment Break

IX. Quality System Regulation (QSR)
            A. History, Purpose, and Scope
            B. Changes from Prior Good Manufacturing Practices (GMPs)
            C. Regulatory Requirements
            D. Quality System Inspection Technique (QSIT)
                        1. Management Controls
                        2. Design Control
                        3. Production and Process Controls
                        4. Corrective and Preventive Action (CAPA)
            E. Integration of QSR Systems
            F. Part 11
            G. Differences between ISO and QSR

X. Promotion and Advertising                                    
            A. Scope of FDA Authority; Promotion and Advertising Policy Staff,
                Office of Compliance, CDRH
                        1. “Label” and “Labeling”
                        2. Advertising
                        3. FDA vs. FTC Authority
            B. “False or Misleading”; Misbranding
            C. Promotion of Unapproved Devices
            D. Off-label Issues
                        1. Off-label Use and Practice of Medicine
                        2. Off-label Issues
            E. First Amendment Issues
                        1. Washington Legal Foundation v. Henney
                        2. Guidance FDA has with Reprints
            F. Claim Substantiation
                        1. Generally
                        2. Comparative Claims
                        3. “Establishment” Claims
            G. Direct-to-Consumer (DTC) Advertising
            H. Monitoring Compliance
                        1. Tradeshows
                        2. Scientific Forums
                        3. Detailers
                        4. Internet
                        5. Remuneration
            I. Federal Trade Commission (FTC) Regulation
            J. FDA Enforcement vs. Non-FDA Enforcement
                        1. False Claims Act and Qui tam Actions

12:15 a.m.-1:30 p.m.   
Lunch

•• Back to Top

1:30 p.m.                     
XI. 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

XII. Enforcement and Compliance
            A. FDA Jurisdiction
                        1. Device                                                           
                        2. Interstate Commerce
                        3. Scope
                        4. Compliance Responsibility
            B. Prohibited Acts and Penalties
                        1. Prohibited Acts - FDCA Section 301
                        2. U.S. Code Title 18
                        3. Penalties
            C. FDA Inspection
                        1. Scope
                        2. FDA Procedures
                        3. Facility/Individual
                        4. Possible Outcomes
            D. Enforcement Process
                        1. Seizure
                        2. Injunction
                        3. Litigation - Federal Rules of Civil Procedure
            E. Other Enforcement/Remedial Possibilities           

XIII.    International Issues
            A. 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
            B. 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)
            C. Imports
                        1. Roles of FDA and Customs and Border Protection (CBP); Inspections
                        2. Grounds for Refusing Admission
                                    a. Detentions
                        3. “Application for Authorization to Relabel and Recondition”
                                    a. Conditions are Fulfilled = Product is Released
                                    b. Conditions are not Fulfilled/Device Still Appears to be in
                                        Violation = Destroyed or Exported
                        4. Import for Export
            C. European Union (EU) Directives
                        1. CE Mark Process; Notified Bodies
                        2. Quality Systems Regulation, Mutual Recognition Agreement,
                            Conformity Assessment Bodies

XIV. Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)                                          
            A. FDA Approval /Clearance
                        1. 510(k)
                        2. IDE/PMA
                        3. Reimbursement Implications:
            B. 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           
            C. Distinguishing FDA Data Needs from CMS Data Needs          
                        1. Patient Selection Criteria for Clinical Trials – ove r65
                        2. Clinical End Points – Non-Inferiority ≠Superior Clinical Benefits
                        3. Proof of Long Term Efficacy – Post Marketing Studies
            D. CMS’ New Policy on Coverage for Clinical Trials and Research,
                and CLIA Waiver Designations
            E. Practical Tips to Link FDA with Reimbursement
                        1. Selecting the Route for Approval/Clearance
                        2. Picking the Predicate Device
                        3. Structuring Clinical Trials
                        4. Labeling to Support Coverage and Reimbursement

5:00 p.m.                     
Adjournment

•• Back to Top

Meeting Date(s) November 17-18, 2009

Hotel Reservations
L'Enfant Plaza Hotel
480 L'Enfant Plaza, SW
Washington, DC 20024
Phone: 202-484-1000 | 800-635-5065
Web: www.lenfantplazahotel.com

Room Rate
$199 single/double + applicable taxes
Please call the hotel and identify yourself as an FDLI Introduction to Medical Device Law conference attendee to receive the rate.

Reservation Cut-Off October 19, 2009

Check-in 3 pm
Check-out 12 Noon

Directions
The L'Enfant Plaza metrorail stop, which you can access from the blue, orange, yellow and green lines, is located directly under the lobby of L'Enfant Plaza Hotel. More information >