Establishing%20Rules%20for:

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• Establishing Rules for
• Medical Device Reports (803)
• Correction and Removal Reports (806)

Presented by Cap Uldriks, FDA Daniel P. Olivier,
CCS
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Objectives

• Define regulatory reporting rules based on
  established standards
• Simplify regulatory reporting decision making
• Establish defensible basis to support compliance
  with reporting regulations
• Reduce risk of non-compliance observations

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AGENDA

• Reporting Regulations
• Evaluating Safety Risks
• Defining the Strategy
• Summary

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Reporting Regulations
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21 CFR Part 803 Medical Device Reporting

• MDR reportable event means
• (1) User facilities become aware of information
  that reasonably suggests a device has or may have
  caused or contributed to a death or serious
  injury or
• (2) Manufacturers or importers become aware of
  information that reasonably suggests one of their
  marketed devices
• (i) May have caused or contributed to a death or
  serious injury, or
• (ii) Has malfunctioned and that the device or a
  similar device marketed by the manufacturer or
  importer would be likely to cause or contribute
  to a death or serious injury if the malfunction
  were to recur.

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Compliance Program Guidance for 21 CFR Part
803Medical Device Reporting

• If the event is likely to cause or contribute to
  death or serious injury" then the event is
  reportable
• The preamble offers the following guidance, i.e.,
  a malfunction report is required when
• 1.The chance of a death or serious injury
  occurring as a result of the recurrence of the
  malfunction is not remote
• 2.The consequences of the malfunction affect
  the device in a catastrophic manner that may lead
  to a death or serious injury (Class I Recall)

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21 CFR Part 806 Corrections and Removal Reporting

• Sec. 806.10 Reports of corrections and removals.
• (a) Each device manufacturer or importer shall
  submit a written report to FDA of any correction
  or removal of a device initiated by them
• (1) To reduce a risk to health posed by the
  device or
• (2) To remedy a violation of the act caused by
  the device which may present a risk to health
  unless the information has already been provided
  under Part 803 or Part 1004 or the action is
  exempt from the reporting under 806.1(b).

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Compliance Program Guidance for 21 CFR Part 806
FDA Corrections and Removals Reporting

• Risk to Health - The key concept to determine
  whether an event is reportable under Part 806
• Use of, or exposure to, the product may cause
  temporary or medically reversible adverse health
  consequences, or an outcome where the probability
  of serious adverse health consequences is remote
  (Class II Recall).

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21 CFR Part 7.3 Recall Class Definitions

• Class I is a situation in which there is
  reasonable probability that the use of, or
  exposure to, a violative product will cause
  serious adverse health consequences or death
  (criteria for 803 reporting)
• Class II is a situation in which there is
  reasonable probability that the use of, or
  exposure to, a violative product may cause
  temporary or medically reversible adverse health
  consequences or where the probability of serious
  adverse health consequences is remote (criteria
  for 806 reporting)
• Class III is a situation in which there is
  reasonable probability that the use of, or
  exposure to, a violative product is not likely to
  cause serious adverse health consequences

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Evaluating Safety Risk
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Risk Evaluation, Severity

• Severity - Assess the worst possible
  consequence, defined by degree of injury or
  illness that could occur. Severity
  classification identified as follows
• Major, may cause death or serious injury
• Moderate, may cause non-serious injury
• Minor, not expected to cause injury

Based on Levels of Concern defined in
Guidance for the Content of Premarket Submissions
for Software Contained in Medical Devices, Food
and Drug Administration, May 11,2005.
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MIL-STD 882D Severity Levels

• Severity Suggested mishap categories
• Catastrophic, could result in death, permanent
  total disability, loss exceeding 1M
• Critical, could result in permanent partial
  disability, or that may result in hospitalization
  of at least three people, 200k-1M loss
• Marginal, could result in injury resulting in
  more than one lost work day, 10K-200K loss
• Negligible, could result in injury resulting in
  less than one lost day, less than 10K

Standard Practice for System Safety,
MIL-STD-882D, Department of Defense, February 10,
2000, Appendix A, Table A-1, page 18
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ISO 149712000 Severity Levels

• Severity levels may be descriptive, e.g.
• Catastrophic
• Serious
• Critical
• Marginal
• Negligible

Medical device - Application of safety risk
management to medical devices, ANSI/AAMI/ISO
149712000 section E.2.2, page 32
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Consolidated Severity Levels
MIL-STD
882D ISO 149712000 FDA Guidance
Catastrophic Catastrophic Major
Serious Major Critical Critical Major Mar
ginal Marginal Moderate Negligible
Negligible Minor
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MIL-STD-882D Risk Evaluation, Probability

• Probability - Probability that a mishap will
  occur during the planned life expectancy of the
  system
• Frequent - Likely to occur often
• (X gt 10-1)
• Probable - Will occur several times in the life
  of the system.
• (10-1 gtX gt10-2)
• Occasional - Likely to occur sometime in the life
  of the system. (10-2 gtX gt10-3)
• Remote - Unlikely but possible to occur in the
  life of the system. (10-3 gtX gt10-6 )
• Improbable - So unlikely, it can be assumed
  occurrence
• may not be experienced
• (X lt 10-6)

Standard Practice for System Safety,
MIL-STD-882D, Department of Defense, February 10,
2000, Appendix A, Table A-2, page 19
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ISO 149712000 Risk Evaluation, Probability

• Probability - Probability estimation examines the
  initiating events or circumstances and the
  sequences of events that are of concern
• Frequent
• Probable
• Occasional
• Remote
• Improbable
• Incredible

Medical device - Application of safety risk
management to medical devices, ANSI/AAMI/ISO
149712000 section E.2.1, page 31
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Proposed Risk Assessment Matrix for FDA Adverse
Event Reporting
Minor
Moderate Major
Frequent Probable Occasional Remote
Improbable

Note Probability level of Incredible from ISO
149712003 not included
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Defining the Strategy
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Compliance Program Guidance for 21 CFR Part
803Medical Device Reporting

• If the event is likely to cause or contribute to
  death or serious injury" then the event is
  reportable
• The preamble offers the following guidance, i.e.,
  a malfunction report is required when
• 1.The chance of a death or serious injury
  occurring as a result of the recurrence of the
  malfunction is not remote
• 2.The consequences of the malfunction affect
  the device in a catastrophic manner that may lead
  to a death or serious injury

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Proposed Risk Assessment Matrix for FDA Adverse
Event Reporting
Minor
Moderate Major
Frequent Probable Occasional Remote
Improbable
MDR MDR MDR

Note Probability level of Incredible from ISO
149712003 not included
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Compliance Program Guidance for 21 CFR Part 806
FDA Corrections and Removals Reporting

• Reports are NOT required IF The information has
  already been reported to FDA under the MDR
  regulation, 21 CFR Part 803 or under 21 CFR 1004
  (Replacement of Electronic Products).
• The key concept for determining when an event is
  reportable is the CAR regulation's definition of
  risk to health
• Use of, or exposure to, the product may cause
  temporary or medically reversible adverse health
  consequences, or an outcome where the probability
  of serious adverse health consequences is remote
  (Class II Recall).

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Proposed Risk Assessment Matrix for FDA Adverse
Event Reporting
Minor
Moderate Major
Frequent Probable Occasional Remote
Improbable
MDR MDR MDR CAR NR
CAR CAR CAR NR NR
NR NR NR NR NR

NR - Not reportable CAR - Reportable under 21 CFR
Part 806 MDR - reportable under 21 CFR Part 803
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Summary
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Defining Reporting Strategy

• Reference to external standards/guidelines
  provides defensibility for decision making
• Established rules provide
• consistency
• use of common terminology
• facilitate training
• Established rules reduce compliance risk

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References

• Medical device - Application of safety risk
  management to medical devices, ANSI/AAMI/ISO
  149712000.
• Guidance for the Content of Premarket Submissions
  for Software Contained in Medical Devices, FDA,
  Office of Device Evaluation, May 11, 2005.
• Standard Practice for System Safety,
  MIL-STD-882D, Department of Defense, February 10,
  2000.
• 21 CFR Part 7 Enforcement Policy, US Federal
  Register, Food and Drug Administration.