FDA QS reg/CLIA Comparison: Overview Open Meeting on the Oversight of LDTs November 22, 2010 Katherine Serrano Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health/FDA Katherine.serrano@fda.hhs.gov

FDA 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 use General Overview: Regulation includes requirements related to methods used in and the facilities and controls for: Designing Purchasing Manufacturing Packaging Labeling Storing Installing Servicing Flexibility of the QS reg: Must apply to many types of devices; different types of manufacturers Not written in a “prescriptive manner”

Clinical Laboratory Improvement Amendments (CLIA): Overview Impetus: Inaccurately read Pap Smears Objective: Establish quality standards for laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results Overview: Labs must enroll and meet all major CLIA quality requirements Personnel Proficiency Testing (PT) Quality Control (Analytic Systems) Patient Test Management (Pre-Analytic and Post-Analytic Systems) Facility Administration Quality Assessment

FDA QS reg/CLIA Comparison FDA/CMS Collaboration to analyze and compare the FDA QS reg and CLIA requirements Summary of the analysis: No conflicting requirements Many CLIA requirements may partially fulfill FDA QS reg requirements Examples: Administrative, personnel, record keeping/storage requirements, etc. Many CLIA requirements are analogous to FDA QS reg requirements Examples: Identification, handling requirements to prevent mix-ups, etc.

FDA 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 requirements Quality requirements for the test development process are a focus of the FDA FDA focus on use of appropriate statistical techniques for sampling plans, validation studies etc.

FDA QS reg/CLIA Comparison: Conclusions Many elements of CLIA already address several requirements of the FDA QS reg Processes and procedures implemented to meet the FDA QS reg will not hinder Labs’ ability to meet CLIA requirements

Thanks! Katherine.serrano@fda.hhs.gov