Making Recall Determinations

Transcription

1 Making Recall Determinations AdvaMed January 23, 2008 Orlando, FL Edward C. Wilson, Jr., Esq. Partner Hogan & Hartson LLP (202) Michael S. Heyl, Esq. Associate Hogan & Hartson LLP (202) Hogan & Hartson LLP. All rights reserved.

2 Legal/Regulatory Dilemma It is Illegal to Ship an Adulterated or Misbranded Device What is adulteration? What is misbranding? What is technical adulteration or misbranding? Enforcement Remedies for Shipping Violative Product Who is potentially responsible for the violations? What are the regulatory/legal consequences to the product, the company and responsible individuals? Hogan & Hartson LLP. All rights reserved. 2

3 Legal/Regulatory Dilemma Despite the statute, FDA frequently allows companies to continue to ship devices that the agency knows are technically adulterated or misbranded Statute v. FDA Practice Causes Legal Dilemma Hogan & Hartson LLP. All rights reserved. 3

4 How Does A Potential Quality Issue Arise? Complaints and service records Trend Analyses Internal quality assurance audits FDA inspections Incoming, in-process and finished product testing Supplier/vendor evaluations Lawsuits Management reviews Medical and Scientific Literature Other potential sources Hogan & Hartson LLP. All rights reserved. 4

5 Raising the Red Flag Are appropriate procedures in place for identifying, and notifying responsible parties of these issues? Are employees trained to know when, how and to whom to raise quality issues? Hogan & Hartson LLP. All rights reserved. 5

6 What Should The Company Do With That Information? Evaluate and Investigate Nonconforming Product (21 C.F.R. section ) Complaint Files (21 C.F.R section ) Determine if Corrective Action is Required Corrective and Preventive Action (21 C.F.R. section ) Hogan & Hartson LLP. All rights reserved. 6

7 What Should The Company Do With That Information? Determine Whether a Medical Device Report Must Be Submitted to FDA Medical Device Reporting (21 C.F.R. Part 803) Determine Applicability of Any International Reporting Requirements Determine Whether a Field Action Is Required, What Type of Action to Take and Whether FDA Must Be Notified Enforcement Policy (21 C.F.R. Part 7) Reports of Removals and Corrections (21 C.F.R. Part 806) Hogan & Hartson LLP. All rights reserved. 7

8 Issues to Consider Regarding Whether a Field Action is Required Written Procedures Designate a Point Person to Lead the Process Health Hazard Evaluation Review of Manufacturing and Design Documentation Review of Complaint and MDR Databases Hogan & Hartson LLP. All rights reserved. 8

9 Issues to Consider Regarding Whether a Field Action is Required Failure (Root Cause) Investigation Ensure investigation is directed by responsible individual(s); all records of investigation become discoverable documents Random versus systemic problems Ensure there are formal protocols in place prior to commencing investigation; and that there is documented support for all conclusions drawn Hogan & Hartson LLP. All rights reserved. 9

10 Issues to Consider Regarding Whether a Field Action is Required Scope (Bracketing) of Issue Identification of Affected Products Stop Manufacturing/Stop Shipment Determinations/Recall Decisions Key: Be Sure That Company is Making Consistent Regulatory Decisions At Each Decision Point Hogan & Hartson LLP. All rights reserved. 10

11 What Type of Field Action is Appropriate Removal Physical return of product Correction In-servicing; Dear Doctor Letters Market Withdrawal Regardless of what YOU call it, if it meets the definition of a Removal or Correction, FDA will call it a Recall Hogan & Hartson LLP. All rights reserved. 11

12 Reports To FDA Removals and Corrections that Meet the Definition of Class I and Class II Recalls Must be Reported to FDA Some Districts expect to be notified of Class III recalls Combined notification with MDR possible Market withdrawals, routine servicing and stock recoveries are not reportable to FDA Hogan & Hartson LLP. All rights reserved. 12

13 Record Keeping Removals and Corrections That Are Not Reportable to FDA Are Still Subject to Record Keeping Requirements of Part 806 Market Withdrawals, Routine Servicing and Stock Recoveries Are Subject to Quality System Regulation Record Keeping Requirements (21 C.F.R. Part 820) Use Templates to Ensure That All Necessary Information is Maintained in Field Action Files Regardless of Whether They Are Reportable Hogan & Hartson LLP. All rights reserved. 13

14 The Question? To Recall or Not to Recall Written Procedures How should the decision be made? Need for consistent decision making Who should make the decision? How should the decision be documented? Clinical, Engineering, Legal, Regulatory, Scientific, Statistician Input Hogan & Hartson LLP. All rights reserved. 14

15 Hypothetical 1 Device Fails to Meet Specification Facts: Complaint rate for hip implant is.5%; internal testing shows 20% of product does not meet specification. It is suspected that that problem is due to the failure to calibrate and maintain a cutting machine in accordance with written procedures; no calibration/pm logs maintained for this equipment. Hogan & Hartson LLP. All rights reserved. 15

16 Hypothetical 1 (Cont d) How Should The Company Proceed to Investigate This Situation? What QSR documentation should be maintained? Is an MDR required to be submitted for this event? Is a field action required? If so, what kind of action would be appropriate? Is FDA required to be notified of the field action? Other possible actions? Hogan & Hartson LLP. All rights reserved. 16

17 Hypothetical 2 External Audit Company hires external auditor to conduct system-wide QSR audit Auditor finds that process validations are inadequate but that there are quality control procedures in place to ensure that released product meets its established specifications. How should the company proceed? Is a field action required? Hogan & Hartson LLP. All rights reserved. 17