Making Recall Determinations

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Making Recall Determinations

AdvaMed

January 23, 2008

Orlando, FL

Edward C. Wilson, Jr., Esq.

Partner Hogan & Hartson LLP (202) 637-5839 [email protected] www.hhlaw.com

Michael S. Heyl, Esq.

Associate Hogan & Hartson LLP (202) 637-5456 [email protected] www.hhlaw.com

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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

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Legal/Regulatory Dilemma

• Despite the statute, FDA frequently allows companies to

continue to ship devices that the agency knows are technically adulterated or misbranded

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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

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“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

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What Should The Company Do

With That Information?

• Evaluate and Investigate

– Nonconforming Product (21 C.F.R. section 820.90) – Complaint Files (21 C.F.R section 820.198)

• Determine if Corrective Action is Required

– Corrective and Preventive Action (21 C.F.R. section

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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

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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

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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

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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

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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

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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

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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

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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

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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.

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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

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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?