Oral Fluid Drug Tests: FDA Perspective. DTAB Meeting January 27, 2011. Courtney C. Harper, Ph.D. Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Food and Drug Administration firstname.lastname@example.org. FDA. FDA.
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January 27, 2011
Courtney C. Harper, Ph.D.
Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Food and Drug Administration
Premarket and Postmarket
Regulation of IVDs
In Vitro Diagnostic Tests are for:
Most DOA tests are Class II and require clearance [510(k)] prior to marketing, including tests for:
All tests must establish adequate:
(cutoff effectiveness, etc.)
Labeling (21 CFR 809.10)
analytical studies only
sponsor provides data to establish that the cutoff is effective (safe and effective balance of FP and FN results)
Example: Impact of collection kit
Example: Self-contained collection
Example: Dilution imprecision
Example: Inappropriate cutoff
Sponsors should discuss their device with FDA as early as possible
A “Pre-IDE” should be used to discuss new tests prior to starting studies. Interactive process to discuss:
510(k) Database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Decision Summary contains the information used to support clearance: