|Peter Tobin, Ph.D.|
Division of Program Operations and Management
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health, FDA
10903 New Hampshire Avenue
Silver Spring, MD 20993
In Vitro Diagnostics (IVDs), Protocol Design, Metrology, Risk Management, Information Systems, Business Process Automation, Quality Management
Proposed Research Project for FDA Commissioner's Fellow
Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988, establishing quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. CLIA requires that clinical laboratories obtain a certificate before accepting materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or the impairment of, or assessment of the health of human beings. The type of CLIA certificate a laboratory obtains depends upon the complexity of the tests it performs. CLIA regulations describe the following three levels of test complexity: waived tests, moderate complexity tests, and high complexity tests. FDA/CDRH is responsible for the CLIA categorization of commercially available IVD tests, and manufacturers whose IVDs “employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible” (42 U.S.C. § 263a(d)(3)) may apply for a waived categorization through the CLIA Waiver by Application process.
As part of the CLIA Waiver Application the manufacturer demonstrates in studies conducted at the intended use sites that the test is accurate and poses an insignificant risk of erroneous results. The manufacturer also demonstrates that the device is simple to use and provides evidence of risk management through studies that validate device controls and robustness related to risk sources such as human factors, environmental factors, and test system integrity. CDRH/OIR is working to develop new tools and approaches to advance the science and conduct of IVD studies in support of CLIA Waiver applications in order to reduce the uncertainties in this process for manufacturers and help innovative and effective IVDs reach patients faster.
The selected fellow will serve in CDRH/OIR in the Division of Program Operations and Management and assist in the development of IVD study protocol design and/or regulatory review tools for CLIA Waiver by Application or other IVD premarket submissions. IVD study protocol design and submission preparation tools will help promote efficient and scientifically valid evidence generation and enhance consistency, quality, and efficiency in the regulatory review process. The fellow will also be afforded an opportunity to contribute to IVD program operation and policy development activities.
Applicants should have:
- A B.S., M.S., or Ph.D. in an engineering or scientific field
- Strong writing and communication skills
- An interest in IVD regulatory policy work and study protocol design
- Guidance for Industry and FDA Staff - Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
- Guidance for Industry and Food and Drug Administration Staff - Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff