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

Issue Date: March 17, 2015
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Investigational Device Exemption (IDE), Premarket Approval (PMA)
Status: Final

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

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 Management System Regulation (QMSR) 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 QMSR requirements.

Download the Guidance Document