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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

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
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 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