1. 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

2. 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”

3. 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

4. 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.

5. 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.

6. 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

7. Thanks!