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MEDICAL DEVICES

REGULATIONS for SUPPLIES, EQUIPMENT, REAGENTS and TESTING

JILL HOAGBS, SBB(ASCP) CQA(ASQ)AABB STAFF LEAD ASSESSOR

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MEDICAL DEVICE REGULATION

MEDICAL DEVICES

◦EQUIPMENT

◦SUPPLIES

◦REAGENTS

◦TEST KITS

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MEDICAL DEVICE REGULATION

AUTHORITY GIVEN BY FDCA

FDA CDRHODE

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MEDICAL DEVICE REGULATION

PREMARKET APPROVAL

PREMARKET NOTIFICATION◦510(k) CLEARED

VARIANCES

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MEDICAL DEVICE REGULATION

21 CFR 820

◦REQUIREMENTS

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MEDICAL DEVICE REGULATION

QUALITY SYSTEM

MANAGEMENT RESPONSIBILITY

QUALITY AUDITS

PERSONNEL

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MEDICAL DEVICE REGULATION

DESIGN CONTROLS◦DESIGN: PLANNING INPUT OUTPUT REVIEW VERIFICATION &VALIDATION

TRANSFER TO PRODUCTION CHANGES

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MEDICAL DEVICE REGULATION

DOCUMENT CONTROLS

PURCHASING CONTROLS

IDENTIFICATION

TRACEABILITY

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MEDICAL DEVICE REGULATION

PRODUCTION CONTROLS:

◦CHANGE CONTROL

◦ENVIRONMENTAL CONTROL

◦CONTAMINATION CONTROL

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MEDICAL DEVICE REGULATION

PRODUCTION CONTROLS:

◦MATERIAL INSPECTION

◦SOFTWARE VALIDATION

◦INSPECTION

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MEDICAL DEVICE REGULATION

PROCESS CONTROLS:

◦WRITTEN INSTRUCTIONS (SOPS)

◦MONITORING

◦REFERENCE STANDARDS

◦APPROVAL of PROCESS & EQUIPMENT

◦SAMPLING for WORKMANSHIP

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MEDICAL DEVICE REGULATION

MEASURING EQUIPMENT

◦CALIBRATION

◦CALIBRATION STANDARDS

◦CALIBRATION RECORDS

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MEDICAL DEVICE REGULATION

ACCEPTANCE ACTIVITIES

◦REVIEW of DATA

◦RELEASE by SIGNATURE

◦RECORDS

ACCEPTANCE STATUS

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MEDICAL DEVICE REGULATION

PACKAGING

HANDLING

STORAGE

DISTRIBUTION

INSTALLATION

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MEDICAL DEVICE REGULATION

NONCONFORMING DEVICE

CAPA

CUSTOMER COMPLAINTS

SERVICING

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MEDICAL DEVICE REGULATION

510(K) SUBMISSION:

◦DEVICE & DATA PRESENTED

◦REVIEWED

◦CLEARED

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MEDICAL DEVICE REGULATION

EXAMPLE :

510(k) CLEARED REAGENT◦C3b CONTROL CELLS◦CLASS II DESCRIPTION USE SUMMARY OF TECHNICAL CHARACTERISTICS

SUMMARY OF PERFORMANCE REACTIVITY STABILITY

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MEDICAL DEVICE REGULATION