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FDLI’s Introduction to Device Law and Regulation. Violations and Enforcement presented by Bradley Merrill Thompson Epstein, Becker & Green PC January 25, 2007. Topics. Part One Inspections Part Two Enforcement Tools Part Three Enforcement Climate. Part One: Inspections.

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Fdli s introduction to device law and regulation

FDLI’s Introduction to Device Law and Regulation

Violations and Enforcement

presented byBradley Merrill Thompson

Epstein, Becker & Green PC

January 25, 2007


Part One Inspections

Part Two Enforcement Tools

Part Three Enforcement Climate

Part one inspections

Part One:Inspections

Inspection topics

Overview of the Process

Overview of the Law

Having a Plan

Overview of the process
Overview of the Process

  • Some reasons for an inspection

    • Routine

    • Directed

    • Follow up

    • Recall effectiveness check

    • Start-up

    • Pre-approval

  • Likelihood of getting inspected

  • Will they call ahead?

  • Use of third parties

  • Remember evidence gathering purpose

Overview of the law
Overview of the Law

  • Section 704 defines the permitted scope and nature very generally

  • Greater scrutiny for drugs and restricted devices

  • Special rules on--

    • Sampling

    • Records (e.g. interstate shipment and sales, pricing, personnel and research)

    • Affidavits

    • Oral questions regarding facts

Having a plan
Having a Plan

  • Address the following stages:

    • Who greets the investigator and what do they do?

      • Does FDA need a warrant or your consent?

    • Who accepts the Notice of Inspection?

    • Who will host the investigator and what will that host do?

    • How will you determine the reason for the inspection?

    • Will you permit the use of a camera?

      • If not, what will you do if the investigator insists?

Having a plan1
Having a Plan

  • More stages—

    • Any limits on when the investigator may inspect?

    • Will the host ever leave the investigator alone?

    • What records and areas may be inspected?

    • What will the host do if the investigator requests samples or an affidavit?

      • Will you charge for samples?

Having a plan2
Having a Plan

  • More stages—

    • Who will be at the close out and what will they do? What will you promise?

    • Will you request a copy of the EIR?

    • What will you do after the inspection?

      • How will you respond to any FD 483?

      • How will you respond to any warning letter?

        • Don’t over promise

        • Don’t under promise

Having a plan3
Having a Plan

  • Communicate the plan

  • Relationship Management:

    • A question of balance

      • Respect for the law

      • Respect for the agency

Part two enforcement tools

Part Two:Enforcement Tools

Enforcement tool topics
Enforcement Tool Topics

  • Prohibited Acts

  • Interstate Commerce Element

  • Agency Remedies

  • Judicial Enforcement

  • FDA’s Choice of Remedies

  • Other Enforcement Activities

  • Preventive Measures

  • Need for Consistency

1 prohibited acts
1. Prohibited Acts

  • Acts of Adulteration or Misbranding on Devices:

    • To be Introduced into Interstate Commerce

    • In Interstate Commerce

    • Held for Sale after Interstate Commerce

1 prohibited acts1
1. Prohibited Acts

  • Other Such Acts

    • Refusing inspection

    • Refusing access to certain documents

    • False guaranty

    • Destroying certain labeling

    • Failure to register an establishment

    • And so on

Interstate commerce element
Interstate Commerce Element

  • The Constitution

  • Element of the offense

3 agency remedies
3. Agency Remedies

  • FDA Discretion

    • Section 306

    • Untitled letters

    • Warning Letters

  • Recalls

    • Firm Initiated

    • Agency Initiated

    • Mandatory

  • Civil Penalty

3 agency remedies1
3. Agency Remedies

  • Revocation or Suspension of Approvals

  • Publicity

  • Administrative Detention

  • Banning Devices

  • Notification and Repair, Replacement or Refund

4 judicial enforcement
4. Judicial Enforcement

  • Civil Penalties

  • Seizures and Condemnation

  • Criminal Penalties

    • Strict Liability Without Criminal Intent

    • Repeat Offenses as Felonies

    • Individual Liability and the Park Doctrine

    • Section 305 Hearing

4 judicial enforcement1
4. Judicial Enforcement

  • Injunction

    • Preliminary Injunctions Before Trial

    • Permanent Injunctions and Consent Decrees

    • Continuous FDA Oversight of Operations

5 fda s choice of remedies
5. FDA’s Choice of Remedies

  • Speed

  • Tactical Leverage

  • Degrees of Complexity

  • Cost

  • Burden of Proof

  • Publicity

  • Impact of the Judgment

  • Forum Shopping

6 other enforcement activities
6. Other Enforcement Activities

  • Other Federal Criminal Statutes

    • Conspiracy, 18 U.S.C. § 371

    • False reports, 18 U.S.C. § 1001

    • Mail fraud, 18 U.S.C. § 1341

    • Perjury, 18 U.S.C. § 1623

  • Private Lawsuits

  • States

  • 7 preventive measures
    7. Preventive Measures

    • Obtain a Guaranty

    • Effective Program to Prevent and Detect Violations of Law (a.k.a. Compliance Program)

    8 need for consistency
    8. Need for Consistency

    One Company Principle

    • Interpretation A may be okay

    • Interpretation B may be okay

    • But if they differ, one company cannot adopt both A and B

    • Caveat: Different facts warrant different treatment

    Part three regulatory environment

    Part Three:Regulatory Environment

    Part three regulatory environment1
    Part Three:RegulatoryEnvironment

    • FDA Trends

    • Implications

    Fda trends
    FDA Trends

    • Strategic Goals for CDRH Postmarket Transformation Initiative

      • Create Culture of Collaboration

      • Develop World Class Data Systems

      • Enhance Risk/Benefit Communication Efforts

      • Collaborate on Enforcement Strategies and Outcomes

    Fda trends1
    FDA Trends

    CDRH Inspections: Inspections for

    Class II & III Domestic Manufacturers

    Fda trends2
    FDA Trends

    • FDA conducted a study of about 300 inspections of medical device manufacturers in FY 2002

      • Characteristics of the inspections

      • Characteristics of the devices inspected

      • Types of QS deficiencies cited in the 483s that were issued

      • Type of action indicated

    Fda trends3
    FDA Trends

    FY 2002 Establishment Inspections:

    Inspection Characteristics

    Fda trends4
    FDA Trends

    FY 2002 Establishment Inspections:

    Device Characteristics

    Fda trends5
    FDA Trends

    QS/GMP Deficiencies in 483s Issued

    Fda trends6
    FDA Trends

    Top 10 Device Observations Used in Turbo EIR (as of 7/2004)

    Fda trends7
    FDA Trends

    FY 2002 Establishment Inspections:

    District Decisions

    Fda trends8
    FDA Trends

    Agency-Wide Warning Letters 1994-2005

    FDA Trends

    Warning Letters: Device-related by

    Percent of Total Issued

    Fda trends9
    FDA Trends

    Warning Letters: Drug-related

    by Percent of Total Issued

    Fda trends10
    FDA Trends

    Consequences of a Medical Device Inspection

    FDA Trends

    Recalls: Agency-Wide 1992-2003

    FDA Trends

    Recalls: CDRH 1998-2003

    Take away points
    Take-Away Points

    • Overall, CDRH enforcement environment becoming tougher

    • Shifting focus –labeling , premarket but GMPs remain important

    • Conservation of limited resources may lead to fewer, yet more focused inspections

    • Recalls are steadily increasing


    • Consider using metrics to help measure (and manage) your compliance

      • Company boards have an obligation to oversee compliance, but need a meaningful assessment

      • Company management needs to assess the impact of investments in the company’s compliance effort, and to manage risk

      • Company employees need a compliance metric to rally around

    • Metrics can form the basis for useful benchmarking

      Our view was, if we could measure it, we could manage it.

      Dan England