Zdrowie i gospodarka · 17.03.2015

Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." This guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable medical devices. This guidance document also provides recommendations for the content and review procedures for premarket notification (510(k)) submissions, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests, and investigational device exemption (IDE) applications, concerning the labeling instructions for reprocessing reusable medical devices. This guidance reflects the scientific advances in knowledge and technology involved in reprocessing reusable medical devices, especially more complex, reusable medical device designs that are more difficult to reprocess.