Hygia Health Services, Inc. is registered with the Food and Drug Administration (FDA) as a third party reprocessor of non-critical and semi-critical medical devices. As an FDA registered reprocessor, Hygia complies with all applicable regulations including:
1. Registration and Listing Requirements
2. Device Reporting Requirements
3. Device Tracking Requirements
4. Device Corrections and Removals Requirements
5. Quality System Regulation
6. Labeling Requirements
7. Premarket Requirements
For current information regarding the FDA's position on the reprocessing of "single use devices," please visit our "Links" page.
