Medical Devices; Proposed Classification for Medical Washer and Medical Washer-Disinfector

Samenvatting

The Food and Drug Administration (FDA) is proposing to classify the medical washer and medical washer-disinfector intended for general medical purposes to clean and dry surgical instruments, decontaminate or disinfect anesthesia equipment, hollowware, and other medical devices into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that FDA intends to use as the special control for these devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying these devices. This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices.