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FDLI’s Introduction to Device Law and Regulation

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

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  1. FDLI’s Introduction to Device Law and Regulation Violations and Enforcement presented byBradley Merrill Thompson Epstein, Becker & Green PC January 25, 2007

  2. Topics Part One Inspections Part Two Enforcement Tools Part Three Enforcement Climate

  3. Part One:Inspections

  4. InspectionTopics Overview of the Process Overview of the Law Having a Plan

  5. 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

  6. 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

  7. 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?

  8. 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?

  9. 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

  10. Having a Plan • Communicate the plan • Relationship Management: • A question of balance • Respect for the law • Respect for the agency

  11. Part Two:Enforcement Tools

  12. 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

  13. 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

  14. 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

  15. Interstate Commerce Element • The Constitution • Element of the offense

  16. 3. Agency Remedies • FDA Discretion • Section 306 • Untitled letters • Warning Letters • Recalls • Firm Initiated • Agency Initiated • Mandatory • Civil Penalty

  17. 3. Agency Remedies • Revocation or Suspension of Approvals • Publicity • Administrative Detention • Banning Devices • Notification and Repair, Replacement or Refund

  18. 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

  19. 4. Judicial Enforcement • Injunction • Preliminary Injunctions Before Trial • Permanent Injunctions and Consent Decrees • Continuous FDA Oversight of Operations

  20. 5. FDA’s Choice of Remedies • Speed • Tactical Leverage • Degrees of Complexity • Cost • Burden of Proof • Publicity • Impact of the Judgment • Forum Shopping

  21. 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

  22. 7. Preventive Measures • Obtain a Guaranty • Effective Program to Prevent and Detect Violations of Law (a.k.a. Compliance Program)

  23. 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

  24. Part Three:Regulatory Environment

  25. Part Three:RegulatoryEnvironment • FDA Trends • Implications

  26. 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

  27. FDA Trends CDRH Inspections: Inspections for Class II & III Domestic Manufacturers

  28. 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

  29. FDA Trends FY 2002 Establishment Inspections: Inspection Characteristics

  30. FDA Trends FY 2002 Establishment Inspections: Device Characteristics

  31. FDA Trends QS/GMP Deficiencies in 483s Issued

  32. FDA Trends Top 10 Device Observations Used in Turbo EIR (as of 7/2004)

  33. FDA Trends FY 2002 Establishment Inspections: District Decisions

  34. FDA Trends Agency-Wide Warning Letters 1994-2005

  35. FDA Trends Warning Letters: Device-related by Percent of Total Issued

  36. FDA Trends Warning Letters: Drug-related by Percent of Total Issued

  37. CDRH BIMO Warning Letters

  38. CDRH BIMO Warning Letters

  39. FDA Trends Consequences of a Medical Device Inspection

  40. FDA Enforcement Statistics FY 2005

  41. FDA Trends Recalls: Agency-Wide 1992-2003

  42. FDA Trends Recalls: CDRH 1998-2003

  43. 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

  44. 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

  45. Questions or Comments?

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