Fdli s introduction to device law and regulation
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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 OneInspections Part TwoEnforcement Tools Part ThreeEnforcement 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


Topics

Topics

Part OneInspections

Part TwoEnforcement Tools

Part ThreeEnforcement Climate


Part one inspections

Part One:Inspections


Inspection topics

InspectionTopics

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


    Fdli s introduction to device law and regulation

    FDA Trends

    Warning Letters: Device-related by

    Percent of Total Issued


    Fda trends9

    FDA Trends

    Warning Letters: Drug-related

    by Percent of Total Issued


    Cdrh bimo warning letters

    CDRH BIMO Warning Letters


    Cdrh bimo warning letters1

    CDRH BIMO Warning Letters


    Fda trends10

    FDA Trends

    Consequences of a Medical Device Inspection


    Fdli s introduction to device law and regulation

    FDA Enforcement Statistics FY 2005


    Fdli s introduction to device law and regulation

    FDA Trends

    Recalls: Agency-Wide 1992-2003


    Fdli s introduction to device law and regulation

    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


    Conclusion

    Conclusion

    • 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


    Questions or comments

    Questions or Comments?


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