FDA Publishes Guidance Document for Reprocessing Medical Devices

August 16, 2000

The Food & Drug Administration (FDA) has published a Guidance Document that authorizes the reprocessing of single-use medical devices under certain conditions. The document was published in the Federal Register and is available on the FDA's Website. The guidelines are likely to increase reprocessing by third-party reprocessors because of the strain of increased paperwork and quality requirements on hospitals. For more information, visit the Food & Drug Administration Website at www.fda.gov.

The Food & Drug Administration (FDA) has published a Guidance Document that authorizes the reprocessing of single-use medical devices under certain conditions. The document was published in the Federal Register and is available on the FDA's Website. The guidelines are likely to increase reprocessing by third-party reprocessors because of the strain of increased paperwork and quality requirements on hospitals. For more information, visit the Food & Drug Administration Website at www.fda.gov.