Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff March 2015

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 of premarket notification submissions [510(k)], 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. Please note that exemption from 510(k) does not mean a device is exempt from compliance with labeling or Quality System (QS) requirements. Manufacturers of 510(k)-exempt devices should follow the recommendations of this guidance pertaining to such requirements, unless, for example, the device is specifically exempted by regulation from specific QS requirements.

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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0293.