OIVD Office Information
The Office of In Vitro Diagnostics Device Evaluation and Safety
(OIVD) is part of the U.S. Food and Drug Administration's Center
for Devices and Radiological Health. The Food and Drug Administration
(FDA) is a government regulatory agency that helps ensure the safety
and effectiveness of cosmetics, foods, drugs, and medical devices
under the Federal Food,
Drug, and Cosmetic Act.
The Office of In Vitro Diagnostic Device Evaluation and Safety
(OIVD) regulates all aspects of in-home and laboratory diagnostic
tests (in vitro diagnostic devices, or IVDs). The Office:
- Helps good new IVDs reach the medical market
- Prevents the sale of unsafe or ineffective IVDs
- Categorizes the complexity of IVDs according to the Clinical
Laboratory Improvement Amendments of 1988 (CLIA '88), thereby
defining the type of regulatory oversight applied to the product.
| Address: |
HFZ-440
2098 Gaither Road
Rockville, MD 20850 |
| Phone Number: |
(240) 276-0450 |
| Fax Number: |
(240) 276-0643 |
|
