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Transcript of Rules for Supporting Part 803 and Part 806 Decision Making Page 1 Establishing Rules for: Medical...
Rules for SupportingPart 803 and Part 806 Decision Making
Page 1
Establishing Rules for:
Medical Device Reports (803) &
Correction and Removal Reports (806)
Establishing Rules for:
Medical Device Reports (803) &
Correction and Removal Reports (806)
Presented by:Cap Uldriks, FDA
Daniel P. Olivier, CCS
Rules for SupportingPart 803 and Part 806 Decision Making
Page 2
ObjectivesObjectives
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
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
Rules for SupportingPart 803 and Part 806 Decision Making
Page 3
AGENDA
AGENDA
Reporting Regulations
Evaluating Safety Risks
Defining the Strategy
Summary
Reporting Regulations
Evaluating Safety Risks
Defining the Strategy
Summary
Rules for SupportingPart 803 and Part 806 Decision Making
Page 4
+Reporting RegulationsReporting
Regulations
Rules for SupportingPart 803 and Part 806 Decision Making
Page 5
21 CFR Part 803: Medical Device Reporting
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.
Rules for SupportingPart 803 and Part 806 Decision Making
Page 6
Compliance Program Guidance for 21 CFR Part 803:
Medical Device Reporting
Compliance Program Guidance for 21 CFR Part 803:
Medical 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)
Rules for SupportingPart 803 and Part 806 Decision Making
Page 7
21 CFR Part 806: Corrections and Removal Reporting
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).
Rules for SupportingPart 803 and Part 806 Decision Making
Page 8
Compliance Program Guidance for 21 CFR Part 806:
FDA Corrections and Removals Reporting
Compliance Program Guidance for 21 CFR Part 806:
FDA Corrections and Removals ReportingRisk 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).
Rules for SupportingPart 803 and Part 806 Decision Making
Page 9
21 CFR Part 7.3: Recall Class Definitions
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
Rules for SupportingPart 803 and Part 806 Decision Making
Page 10
+Evaluating Safety Risk
Evaluating Safety Risk
Rules for SupportingPart 803 and Part 806 Decision Making
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Risk Evaluation, Severity
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.
Rules for SupportingPart 803 and Part 806 Decision Making
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MIL-STD 882D* Severity Levels
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
Rules for SupportingPart 803 and Part 806 Decision Making
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ISO 14971:2000* Severity Levels
ISO 14971:2000* 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 14971:2000 section E.2.2, page 32
Rules for SupportingPart 803 and Part 806 Decision Making
Page 14
Consolidated Severity LevelsConsolidated Severity Levels
MIL-STD 882D ISO 14971:2000 FDA Guidance
Catastrophic Catastrophic Major
Serious Major
Critical Critical Major
Marginal Marginal Moderate
Negligible Negligible Minor
Rules for SupportingPart 803 and Part 806 Decision Making
Page 15
MIL-STD-882D* Risk Evaluation, Probability
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 > 10-1)
– Probable - Will occur several times in the life of the system. (10-1 >X >10-2)
– Occasional - Likely to occur sometime in the life of the system. (10-2 >X >10-3)
– Remote - Unlikely but possible to occur in the life of the system. (10-3 >X >10-6 )
– Improbable - So unlikely, it can be assumed occurrence may not be experienced(X < 10-6)
* Standard Practice for System Safety, MIL-STD-882D, Department of Defense, February 10, 2000, Appendix A, Table A-2, page 19
Rules for SupportingPart 803 and Part 806 Decision Making
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ISO 14971:2000* Risk Evaluation, Probability
ISO 14971:2000* 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 14971:2000 section E.2.1, page 31
Rules for SupportingPart 803 and Part 806 Decision Making
Page 17
Proposed Risk Assessment Matrix for FDA Adverse Event
Reporting
Proposed Risk Assessment Matrix for FDA Adverse Event
Reporting Minor Moderate Major
Frequent
Probable
Occasional
Remote
Improbable
Note: Probability level of “Incredible” from ISO 14971:2003 not included
Rules for SupportingPart 803 and Part 806 Decision Making
Page 18
Defining the StrategyDefining the Strategy
Rules for SupportingPart 803 and Part 806 Decision Making
Page 19
Compliance Program Guidance for 21 CFR Part 803:
Medical Device Reporting
Compliance Program Guidance for 21 CFR Part 803:
Medical 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
Rules for SupportingPart 803 and Part 806 Decision Making
Page 20
Proposed Risk Assessment Matrix for FDA Adverse Event
Reporting
Proposed Risk Assessment Matrix for FDA Adverse Event
Reporting Minor Moderate Major
Frequent
Probable
Occasional
Remote
Improbable
Note: Probability level of “Incredible” from ISO 14971:2003 not included
MDR
MDR
MDR
Rules for SupportingPart 803 and Part 806 Decision Making
Page 21
Compliance Program Guidance for 21 CFR Part 806:
FDA Corrections and Removals Reporting
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).
Rules for SupportingPart 803 and Part 806 Decision Making
Page 22
Proposed Risk Assessment Matrix for FDA Adverse Event
Reporting
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
Rules for SupportingPart 803 and Part 806 Decision Making
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SummarySummary
Rules for SupportingPart 803 and Part 806 Decision Making
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Defining Reporting Strategy
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
Rules for SupportingPart 803 and Part 806 Decision Making
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References
References
Medical device - Application of safety risk management to medical devices, ANSI/AAMI/ISO 14971:2000.
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.