Presentation on theme: "FDA QS reg/CLIA Comparison: Overview"— Presentation transcript:
1FDA QS reg/CLIA Comparison: Overview Open Meeting on the Oversight of LDTsNovember 22, 2010Katherine SerranoOffice of In Vitro Diagnostic Device Evaluation and SafetyCenter for Devices and Radiological Health/FDA
2FDA Quality System Regulation (QS reg): Overview Purpose: To ensure that medical devices consistently meet applicable requirements and specifications and are generally safe and effective for their intended useGeneral Overview: Regulation includes requirements related to methods used in and the facilities and controls for:DesigningPurchasingManufacturingPackagingLabelingStoringInstallingServicingFlexibility of the QS reg:Must apply to many types of devices; different types of manufacturersNot written in a “prescriptive manner”
3Clinical Laboratory Improvement Amendments (CLIA): Overview Impetus: Inaccurately read Pap SmearsObjective: Establish quality standards for laboratory testing to ensure the accuracy, reliability, and timeliness of patient test resultsOverview: Labs must enroll and meet all major CLIA quality requirementsPersonnelProficiency Testing (PT)Quality Control (Analytic Systems)Patient Test Management (Pre-Analytic and Post-Analytic Systems)Facility AdministrationQuality Assessment
4FDA QS reg/CLIA Comparison FDA/CMS Collaboration to analyze and compare the FDA QS reg and CLIA requirementsSummary of the analysis:No conflicting requirementsMany CLIA requirements may partially fulfill FDA QS reg requirementsExamples: Administrative, personnel, record keeping/storage requirements, etc.Many CLIA requirements are analogous to FDA QS reg requirementsExamples: Identification, handling requirements to prevent mix-ups, etc.
5FDA QS reg/CLIA Comparison: Summary of the analysis (continued):There are some cases where CLIA requirements do not address some elements of the FDA QS reg requirementsQuality requirements for the test development process are a focus of the FDAFDA focus on use of appropriate statistical techniques for sampling plans, validation studies etc.
6FDA QS reg/CLIA Comparison: Conclusions Many elements of CLIA already address several requirements of the FDA QS regProcesses and procedures implemented to meet the FDA QS reg will not hinder Labs’ ability to meet CLIA requirements