REGULATIONS for SUPPLIES, EQUIPMENT, REAGENTS and TESTING JILL HOAG BS, SBB(ASCP) CQA(ASQ) AABB STAFF LEAD ASSESSOR 1

MEDICAL DEVICES EQUIPMENT SUPPLIES REAGENTS TEST KITS 2

AUTHORITY GIVEN BY FDCA FDA CDRH ODE 3

PREMARKET APPROVAL PREMARKET NOTIFICATION 510(k) CLEARED VARIANCES 4

21 CFR 820 REQUIREMENTS 5

QUALITY SYSTEM MANAGEMENT RESPONSIBILITY QUALITY AUDITS PERSONNEL 6

DESIGN CONTROLS DESIGN: PLANNING INPUT OUTPUT REVIEW VERIFICATION &VALIDATION TRANSFER TO PRODUCTION CHANGES 7

DOCUMENT CONTROLS PURCHASING CONTROLS IDENTIFICATION TRACEABILITY 8

PRODUCTION CONTROLS: CHANGE CONTROL ENVIRONMENTAL CONTROL CONTAMINATION CONTROL 9

PRODUCTION CONTROLS: MATERIAL INSPECTION SOFTWARE VALIDATION INSPECTION 10

PROCESS CONTROLS: WRITTEN INSTRUCTIONS (SOPS) MONITORING REFERENCE STANDARDS APPROVAL of PROCESS & EQUIPMENT SAMPLING for WORKMANSHIP 11

MEASURING EQUIPMENT CALIBRATION CALIBRATION STANDARDS CALIBRATION RECORDS 12

ACCEPTANCE ACTIVITIES REVIEW of DATA RELEASE by SIGNATURE RECORDS ACCEPTANCE STATUS 13

PACKAGING HANDLING STORAGE DISTRIBUTION INSTALLATION 14

NONCONFORMING DEVICE CAPA CUSTOMER COMPLAINTS SERVICING 15

510(K) SUBMISSION: DEVICE & DATA PRESENTED REVIEWED CLEARED 16

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EXAMPLE : 510(k) CLEARED REAGENT C3b CONTROL CELLS CLASS II DESCRIPTION USE SUMMARY OF TECHNICAL CHARACTERISTICS SUMMARY OF PERFORMANCE REACTIVITY STABILITY 19

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