Program Description

If you are involved in the medical device industry, Food and Drug Administration (FDA) regulatory issues are bound to arise. Put yourself in the know and be prepared!  In this updated, interactive two-day program, you will learn the essential elements of FDA medical device and diagnostics regulation in a systematic and comprehensive way from experts in the field. The first day will focus on the legal framework, FDA’s organization and premarket requirements while 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 to help you develop a clearer understanding of how they work. Case studies are included for practical application of medical device concept. You’ll receive an overview of the FDA regulatory structure, obtain pointers on how to prepare a successful 510(k) submission and bring you up to date on recent 510(k) activities. Further you will explore new and developing FDA policies and procedures affecting all phases of medical device regulation. This program will lead you to think like a seasoned medical device regulatory professional. Additionally, you will learn how FDA enforces the laws passed by Congress and some of the “hot” issues in the ever-changing FDA regulatory landscape. This meeting can help you and your organization stay in compliance with FDA regulations, get products approved, and help minimize regulatory problems.

You Should Attend This Program if you need an overview on medical device law and regulation or a refresher of medical device concepts. The following personnel will benefit from attending this course:

• Regulatory and clinical affairs, research and development, quality control, marketing and management professionals of medical device companies
• Federal or state agency staff reviewing medical device applications
• Associates working in law firms with a Food and Drug Administration (FDA) practice and other lawyers who have an interest in FDA medical device issues
• Personnel in legal departments at medical device companies, contract research organizations and medical institutions

This program is also a good refresher and update meeting for seasoned regulatory affairs and legal professionals who much keep current with FDA medical device regulatory developments.

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.”

Speakers

Christine P. Bump, Attorney, Goodwin Procter LLP
Benjamin L. England, CEO/President, FDAImports.com
Jennifer A. Henderson, JD, MPH, Attorney, Hogan Lovells LLP
Robert J. Klepinski, Officer, Fredrikson & Byron, P.A.
Maria E. Gonzalez Knavel, Partner, Foley and Lardner LLP
Susan J. Matthees, Associate, Hyman, Phelps & McNamara, P.C.
Elaine C. Messa, RAC, Director, Medical Device Quality Systems and Compliance,
Becker & Associates Consulting, Inc.
Carol A. Pratt, PhD, JD, Partner, K&L Gates
Michael A. Swit, Vice President, The Weinberg Group Inc.
Stacy L. Taylor, Partner, DLA Piper LLP US
Karen A. Weaver, JD, RPh, Vice-President & Assoc. General Counsel, Regulatory,
CareFusion Corporation

Attendee Handouts

FDLI’s Statutory Supplement: Federal Food, Drug, and Cosmetic Act, 2010 Edition
Binder of speaker handout materials

Continuing Legal Education (CLE) Credits

Continuing Legal Education credits are available after attending this program. FDLI applies directly to Ohio, Pennsylvania and Virginia. These states are generally recognized as approved jurisdictions by other states. Please contact your Bar Association for guidance.

CLE credits for Introduction to Medical Device Law and Regulation have been approved for the following:

Pennsylvania = 13.0 credits
Virginia = 13.5 credits

Registration Fees

$1,095 Member
$1,525 Nonmember

$ 895 Government Member
$ 995 Government Nonmember

$ 895 Academic Member
$ 995 Academic Nonmember

$1,095 Sole Practitioner Member
$1,525 Sole Practitioner Nonmember

$ 375 Student Member
$ 450 Student Nonmember
(Please call FDLI's Customer Service at (202) 371-1420 to receive this rate)

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 service@fdli.org,
if you have any questions about your conference registration or CD order.

November 15

8:00 a.m.
Registration and Continental Breakfast

8:30 a.m.
FDLI Welcome and Announcements

8:45-10:00 a.m.
I. Overview of Medical Device Law and Regulation

        A. Sources of Law
                1. Statutes
                        a. Federal Food, Drug and Cosmetic Act of 1938 (FDCA)
                        b. Radiation Control for Health and Safety Act of 1968  (RCHS)
                        c. 1976 Medical Device Amendments
                        d. Safe Medical Devices Act of 1990 (SMDA)
                        e. Mammography Quality Standards Act of 1992 (MQSA)
                        f. Food and Drug Administration Modernization Act of 1997 (FDAMA)
                        g. Medical Device User Fee and Modernization Act of 2002  (MDUFMA)
                                i.  User Fees
                                ii.  Reprocessed Single-Use Devices
                        h. Medical Device User Fee Stabilization Act of 2005 (MDUFSA)
                        i. The Food and Drug Administration Amendments Act of 2007 (FDAAA)
                        j. Patient Protection and Affordable Care Act (Healthcare Reform 2010)
                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”
                        a. Determining if a Product is a Device; Section 513(g) Process
                        and pre-IDE Meetings and Informal Inquiries
                        b. Gray Area Products (e.g. medical software, exercise vs. rehabilitation)
                2. Device Classification and Examples
                        a. Definitions of Class I, II, III
                        b. General and Special Controls
                3. Combination Products
                        a. CDRH-CDER Intracenter Agreement
                        b. CDRH-CBER Intracenter Agreement
                        c. Designation Requests
                        d. Office of Combination Products (OCP)
                        e. Primary Mode of Action (PMOA)
                        f. Good Manufacturing Practices
                        g. Postmarketing Safety Reporting
        C. General Nature of Requirements and Restrictions
                1. Product Testing
                        a. Preclinical Testing/ Good Laboratory Practices (GLPs)
                        b. Clinical Trials/Good Clinical Practices (GCPs)
                        c. Oversight of Laboratory-Developed Tests (LDTs)
                2. Access to Market
                        a. Premarket Notification (510(k))
                        b. Premarket Approval Application (PMA)
                        c. 510(k) Exempt
                3. Manufacturing
                4. Marketing/Promotion
                5. Reporting
                6. Registration and Listing
        D. Accessing Information
                1. Confidentiality
                2. Freedom of Information Act (FOIA)
                3. Disclosure
        E. Electronic Products

10:00-10:30 a.m.
II. Organizational Structures

        A.U.S. Department of Health and Human Services, Food and Drug
        Administration, CDRH
                1. Office of the Center Director and Responsibilities
                        a. Director
                        b. Ombudsman
                2. Office of Device Evaluation (ODE)
                3. Office of In Vitro Diagnostic Device Evaluation and Safety
                        a. Clinical Laboratory Improvement Amendments of 1988 (CLIA)
                        and Waiver Applications
                4. Office of Compliance
                        a. Division of Bioresearch Monitoring (DBM)
                        b. Promotion and Advertising Policy Staff
                5. Office of Surveillance and Biometrics
                6. Office of Science and Engineering Laboratories
                7. Division of Small Manufacturers, International and Consumer Assistance
                8. A Word about Tobacco
        B. FDA’s Office of Regulatory Affairs (ORA)
                1. Office of Criminal Investigation (OCI)
        C. FDA’s District Offices; FDA’s International Offices
        D. Office of the Chief Counsel (OCC); U.S. Department of Justice,
        Office of Consumer Litigation – FDA’s Attorneys
        E. State Involvement with Medical Device Regulation
        F. Transparency, Working with FDA; How to/When to Communicate with FDA

10:30-10:45 a.m.
Refreshment Break

10:45 a.m.-12:15 p.m.
III. Premarket Notification (510(k))

        A. Overview and the Institute of Medicine (IOM) Review
        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
                        a. Substantially Equivalent (SE)
                        b. Request for Additional Information
                        c. Not Substantially Equivalent (NSE)
                3. De Novo Review
                4. Other Issues
                        a. General/Specific Intended Use
                        b. Special Controls
        F. Use of Standards
        G. Third Party Review
        H. User Fees and Rates; Reauthorization
        I. Modifications to a Cleared Device
        J. Update on Total Product Life Cycle: Infusion Pump --
        Premarket Notification Submissions
        K. 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).

12:15-1:15 p.m.
Lunch

1:15-1:40 p.m.
IV. Registration and Listing

        A. Who Must Register/List
        B. How to Register/List
        C. When to Register/List
        D. Updates to Device Listing
        E. U.S. Agents
        F. Exemptions

1:40-2:40 p.m.
V. Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRB’s)
and Informed Consent

        A. Overview
        B. ‘Significant Risk’ (SR) vs. ‘Non-Significant Risk’ (NSR) Devices
        C. Exemptions
        D. Submitting an IDE
                1. Contents of an IDE Application
                2. Amendments
        E. FDA Actions
        F. IDE Supplements
        G. Abbreviated Requirements (NSRD study)
        H. Treatment IDEs
        I. Institutional Review Board (IRB)
                1. Composition
                2. Operations
                3. Records
                4. Reports
        J. Informed Consent
                1. Required Elements
                2. Additional Elements
                3. Waivers
                4. Emergency Use
        K. Promotion/Commercialization Including Solicitation

2:40-2:55 p.m.
Refreshment Break

2:55-3:50 p.m.
VI. Clinical Investigations: Sponsor Responsibilities and Compliance Issues

        A. Clinical Trial Sponsor’s Responsibilities
                1. 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

3:50-5:00 p.m.
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

November 16

8:00 a.m.
Continental Breakfast

8:30-8:40 a.m.
FDLI Announcements

8:40-9:20 a.m.
VIII. 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:
                        a. Healthcare Common Procedure Coding System (HCPCS)
                        Product Codes and Picking the Predicate Device
                        b. Coverage of Category B – IDE Devices
        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 – over 65
                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

9:20-10:20 a.m
IX. Post Marketing Issues

        A. Adverse Events/Product Problems
                1. Complaint Handling
                2. Medical Device Reporting (MDR)
                        a. Purpose
                        b. Definitions
                        c. Requirements
                        d. Reporting Forms
                        e. Examples
                        f. Electronic MDR Proposed Rule
        B. Product Recalls
        C. Reports of Corrections and Removals
        D. Safety Alerts and Physician Communication
        E. Ongoing Monitoring of Device Performance
                1. Conditions of PMA Approval/510(k) Clearance
                2. Statutory Programs
                        a. Device Tracking
                        b. Postmarket Surveillance
        F. Risk Communication Initiatives
        G. Medical Device Home Use Initiative

10:20-10:35 a.m.
Refreshment Break

10:35-11:45 a.m.
X.Quality System Regulation (QSR)

        A. History, Purpose and Scope
        B. Regulatory Requirements
        C. Quality System Inspection Technique (QSIT)
                1. Management Controls
                2. Design Control
                3. Production and Process Controls
                4. Corrective and Preventive Action (CAPA)
        D. Integration of QSR Systems
        E. Part 11
        F. Differences between International Standards Organization (ISO) and QSR

11:45 a.m.-1:00 p.m.
Lunch

1:00-2:00 p.m.
XI. 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 and FTC Jurisdictions
        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 Promotion
        E. First Amendment Issues
                1. Washington Legal Foundation v. Henney
                2. FDA Reprint Guidance
        F. Claim Substantiation
                1. Generally
                2. Comparative Claims
                3. “Establishment” Claims
        G. Direct-to-Consumer (DTC) Advertising, Social and Electronic Media
        H. Monitoring Compliance
                1. Tradeshows
                2. Scientific Forums
                3. Detailers
                4. Internet
         I. FDA Enforcement vs. Non-FDA Enforcement
                1. False Claims Act and Qui tam Actions

2:00-3:00 p.m.
XII. 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.

3:00-3:15 p.m.
Refreshment Break

3:15-4:15 p.m.
XIII. 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
                        a. Adulteration - FDCA Section 501
                        b. Misbranding - FDCA Section 502
                2. U.S. Code Title 18
                        a. Crimes and Criminal Procedure - Section 1001 - Statements
                3. Penalties
                        a. Administrative Sanctions
                                (i) Civil Money Penalties
                                (ii) Cease Distribution and Notification Orders and Mandatory Recall
                                (iii) Other Section 518 Remedies
                                (iv) Administrative Detention
                                (v) Device Ban
                                (vi) Import Detention/Alerts/Refusal of Admission
                        b. Judicial
                                (i) Seizure
                                (ii) Injunction
                                (iii) Criminal Prosecution
                4. FDA’s Use of Publicity
        C. FDA Inspection
                1. Scope
                        a. Device
                        b. Interstate
                        c. Authority FDCA Section 703-704
                2. FDA Procedures
                        a. Investigations Operations Manual (IOM)
                                (i) Program
                                (ii) Assignment
                                (iii) Office of Criminal Investigations
                        b. Credentials/Closure
                                (i) FORM FDA 482
                                (ii) Reasonable Time, Limits, Manner
                                (iii) Management Conference FORM FDA 483/No 483
                3. Facility/Individual
                        a. Responsibility and Rights
                        b. Policies
                        c. Inspection Management
                        d. Daily Meetings/Management Committee
                        e. Supply Chain Integrity
                4. Possible Outcomes
                        a. No FORM FDA 483
                                (i) Generally Good News
                        b. FORM FDA 483
                                (i) Respond
                                (ii) Establishment Inspection Report (EIR)
                        c. Warning Letter
                                (i) Export Certificate Denial
                                (ii) Document Response
                                (iii) Possible FDA Meeting Resolution
                        d. Untitled Letters
        D. Enforcement Process
                1. Seizure
                        a. Claim/No Claim to Seized Device
                        b. Claim Discovery Litigation Federal Rules of Civil Procedures (FRCP)
                        c. Settlement or Trial Verdict/Appeal
                2. Injunction
                        a. Department of Justice Notice
                        b. Voluntary Consent Decree
                        c. Defense Litigation
                        d. Trial Verdict/Appeal
                3. Criminal Prosectution
                4. Litigation-FRCP
                        a. Answer
                        b. Interrogatories, Admissions, Document Access, Depositions
                        c. Preparation for Trial
                        d. FDA Burden of Proof Trial and Settlement or Verdict
                        e. Appeal Process
                5. Warning Letters/Untitled Letters
        E. Other Enforcement/Remedial Possibilities
                1. Office of Inspector General
                2. Federal Trade Commission
                3. Securities and Exchange Commission
                4. States Rights
                        a. Civil Criminal
                        b. Tort Liability
                                (i) Preemption
        F. FDA Commissioner’s Enforcement Initiatives
                1. Post-Inspection Deadlines
                2. Shift in OCC Review
                3. Development of Risk Control and Enforcement Strategies
                with Regulatory Partners
                4. Increased Commitment to Warning Letter and Recall Follow-Up
                5. Swift, Aggressive, Immediate Enforcement Action When Indicated
                6. Warning Letter Close-Out Process

4:15-5:00 p.m.
XIV. 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
        D. European Union (EU) Directives
                1. CE Mark Process; Notified Bodies
                2. Mutual Recognition, Agreement, Conformity Assessment Bodies
        E. FDA’s International Posts

5:00 p.m.
Adjournment

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