Zdrowie i gospodarka · 07/02/2002

FDA Publishes Revised Guidance for Medical Washers and Washer-Disinfectors

The FDA has released a revised draft guidance document outlining the content and format requirements for 510(k) submissions of medical washers and washer-disinfectors, which will serve as a special control for class II devices if classified accordingly, and is also proposing a rule to classify these devices as class II.