Business · 05/11/1998

FDA Releases Draft Guidance for 510(k) Submissions of Washers and Washer-Disinfectors

The Food and Drug Administration (FDA) has released a draft guidance document outlining the content and format requirements for 510(k) submissions of washers and washer-disinfectors intended for processing reusable medical devices. The document aims to provide specific directions for applicants and interested parties to submit their 510(k) submissions to the FDA.