Presented by: Cap Uldriks, FDA Daniel P. Olivier, CCS · zDefining the Strategy zSummary zReporting...

Rules for SupportingPart 803 and Part 806 Decision Making

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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


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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


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AGENDAAGENDA

Reporting Regulations

Evaluating Safety Risks

Defining the Strategy

Summary

Reporting Regulations

Evaluating Safety Risks

Defining the Strategy

Summary


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+Reporting RegulationsReporting Regulations


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21 CFR Part 803: Medical Device Reporting21 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 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)


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21 CFR Part 806: Corrections and Removal Reporting21 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 Definitions21 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 Evaluating Safety Risk


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Risk Evaluation, SeverityRisk 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 LevelsMIL-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 14971:2000* Severity LevelsISO 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


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Consolidated Severity LevelsConsolidated Severity Levels

MIL-STD 882D ISO 14971:2000 FDA GuidanceCatastrophic Catastrophic Major

Serious Major

Critical Critical Major

Marginal Marginal Moderate

Negligible Negligible Minor


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MIL-STD-882D* Risk Evaluation, ProbabilityMIL-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


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ISO 14971:2000* Risk Evaluation, ProbabilityISO 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


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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 14971:2003 not included


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Defining the StrategyDefining the Strategy


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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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Minor Moderate Major

Frequent

Probable

Occasional

Remote

Improbable

Note: Probability level of “Incredible” from ISO 14971:2003 not included

MDR

MDR

MDR


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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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Minor Moderate MajorFrequent

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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SummarySummary


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Defining Reporting StrategyDefining 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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ReferencesReferences

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.

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Presented by: Cap Uldriks, FDA Daniel P. Olivier, CCS · zDefining the Strategy zSummary zReporting...

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