Medical Devices

Office of the Center Director Final Guidance

This page lists final guidance documents developed by CDRH’s Office of the Center Director. For a list of current draft guidance documents, please see the Draft Guidance page.

Some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title.

Office of the Center Director Final Guidance Documents

TitleOrganizationDoc #Date
General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 576KB) OCD 1300013 07/29/16
Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Guidance for Industry and Food and Drug Administration Staff OCD 1821 07/30/14
Center for Devices and Radiological Health Appeals Processes - Guidance for Industry and Food and Drug Administration Staff OCD 1742 05/17/13
Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards OCD 321 09/17/07

Page Last Updated: 07/28/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.