Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors - Three Additional Questions: Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocessors
Published: 2003-07-16
Status: Final Type: Guidance Document Category: Quality / QMSR / Manufacturing Docket: FDA-2020-D-0957
Official Source
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 PDF: https://www.fda.gov/media/71124/download
Official Full Text
For questions regarding devices regulated by the Center for Devices and Radiological Health, contact the Infection Control Devices Branch (INCB) at (301) 796-5580.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
The Least Burdensome Approach We believe we should consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be found on the Internet at http://www.fda.gov/cdrh/resolvingdisputes/ombudsman.html.
Questions related to REGISTRATION AND DEVICE LISTING
Question: My establishment is registered as a manufacturer of medical devices, some of which are labeled for single use. We also reprocess for reuse some of the single-use devices that we manufacture. Do we have to add the establishment operation type of "Reprocessor of Single-Use Devices" to our existing registration information?
Answer: Yes, your establishment needs to be registered for all of the operations that are being performed at the same location.
Question: My establishment is registered as a manufacturer of medical devices, some of which are labeled for single use. We also reprocess for reuse some of the single-use devices that we manufacture. Do we have to update our existing device listing information?
Answer: Yes, your establishment needs to have all of the operations that are being performed on a particular device listed with FDA.
Question related to HOSPITAL AND THIRD PARTY REPROCESSORS
Question: Must all hospitals that use reprocessed devices intended for single use comply with the FDA requirements applicable to medical device manufacturers?
Answer: No. Only those hospitals that actually reprocess medical devices labeled for single use must comply with FDA’s medical device requirements applicable to manufacturers. FDA’s regulatory requirements do not apply to hospitals that use a third party reprocessor to reprocess SUDs for reuse.