Reprocessed Single Use Medical Devices

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FAQ: Reprocessing and Reuse of Single-Use Devices, …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-about-reprocessing-and-reuse-single-use-devices-third-party-and-hospital-0

Third-party and hospital reprocessors of single- use devices (SUDs) are subject to all the regulatory requirements currently applicable to original equipment manufacturers, including...

Reprocessing of Reusable Medical Devices | FDA

https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices

Reprocessing of Reusable Medical Devices Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients. …

Labeling Recommendations for Single-Use Devices …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/labeling-recommendations-single-use-devices-reprocessed-third-parties-and-hospitals

The “ Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA ” document provides guidance to …

Reprocessing of Reusable Medical Devices: Information …

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/reprocessing-reusable-medical-devices-information-manufacturers

Reprocessing of Reusable Medical Devices: Information for Manufacturers Reusable medical devices are devices that health care providers can reprocess and reuse on …

Reuse of Single-Use Medical Devices - Centers for …

https://www.cdc.gov/infectioncontrol/guidelines/disinfection/reuse-of-devices.html

Reuse of single-use devices increased as a cost-saving measure. Approximately 20 to 30% of U.S. hospitals reported that they reuse at least one type of …

Single-Use (Disposable) Devices | FAQs | Infection …

https://www.cdc.gov/oralhealth/infectioncontrol/faqs/single-use-devices.html

According to the Food and Drug Administration’s (FDA’s) guidance entitled Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals …

FDA Updates Guidance on Reprocessing of Single-Use …

https://www.mddionline.com/news/fda-updates-guidance-reprocessing-single-use-devices

FDA's revised guidance comes at a time when certain states have passed or are considering laws regarding the use of reprocessed SUDs. A Utah law “requires a reprocessor of a …

MDUFMA 2002 Validation Data 510(k)s for Reprocessed …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-and-modernization-act-2002-validation-data-premarket-notification

Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510 (k)s) for Reprocessed Single-Use Medical Devices …