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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