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  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis - Guidance for Industry and Food and Drug Administration Staff

Read the Special Controls Document

Issue Date: 05/30/1997

Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Device Evaluation

This document reflects the current review guidance for water purification components and systems for hemodialysis. It is based on 1) current scientific knowledge, 2) clinical experience, 3) previous submissions by manufacturers to the Food and Drug Administration (FDA), and 4) the Safe Medical Devices Act of 1990 and FDA regulations in the Code of Federal Regulations (CFR). As advances are made in science and medicine, and changes occur in implementation of Congressional legislation, these review criteria will be re-evaluated and revised as necessary.