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Food and Drug Administration (FDA)'s impact on laboratory performance: FDA's perspective
1Division of Clinical Laboratory Devices, Food and Drug Administration, Rockville, MD 20850, USA.
Clinical Chemistry
|May 1, 1996
Summary
The Food and Drug Administration (FDA) reviews clinical laboratory devices, ensuring new and existing in vitro diagnostic tests are safe and effective through rigorous premarket evaluations and standardized scientific review models.
Area of Science:
- Medical Devices
- Regulatory Science
- Clinical Diagnostics
Background:
- The Division of Clinical Laboratory Devices oversees premarket review for in vitro diagnostic (IVD) devices.
- Over 1000 diverse applications are processed annually.
- Regulatory pathways include 510(k) submissions for new versions of existing devices and de novo applications for novel devices.
Purpose of the Study:
- To outline the regulatory framework for in vitro diagnostic devices.
- To describe the review objectives for different types of device submissions.
- To highlight the FDA's role in ensuring device quality and safety.
Main Methods:
- Premarket review of in vitro diagnostic devices.
- Evaluation of 510(k) submissions for substantial equivalence.
- Assessment of de novo applications for safety and effectiveness.
Main Results:
- The FDA processes over 1000 diverse IVD applications yearly.
- Standardized models for scientific review are a key regulatory focus.
- The FDA establishes safety and effectiveness thresholds and ensures proper data and labeling.
Conclusions:
- The FDA's oversight ensures the quality, safety, and effectiveness of clinical laboratory devices.
- Standardized review processes are critical for regulatory decision-making.
- Objective review and clear labeling support the intended use of IVD devices.