Questions and Answers for the FDA Reviewer Guidance: Labeling Reuseable Medical211 Devices for Reprocessing in Health Care Facilities

摘要

This guidance provides recommendations regarding the content of reuse211u001einstructions in labeling for reusable medical devices. the recommendations are 211u001ealso applicable to the initial processing of single-use only and reusable devices 211u001ethat are supplied nonsteril, and reprocessing of certain sterile, single-use only 211u001eimplantable devices if they become contaminated before implantation (e.g., 211u001eorthopedic implants). The guidance is primarily directed to FDA personnel who are 211u001eresponsible for the evaluation of premarket notification submissions (510(k)s), 211u001epremarket approval applications (PMAs), and investigational device exemptions 211u001eapplications (IDEs). The guidance will also assist persons preparing 510(k)s, 211u001ePMAs, and IDEs for submission to FDA.