Medical Devices

Office of Communication and Education Final Guidance

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 For a list of current draft guidance documents, please see the Draft Guidance page.

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Office of Communication and Education Final Guidance Documents

TitleOrganizationDoc #Date
FY 2016 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (PDF - 317KB) CBER CDRH 2016 08/03/15
Guidance for Industry and FDA Staff - Impact-Resistant Lenses: Questions and Answers OCE/DICE 23 09/02/10
Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs) OCE/DHC 1645 07/19/07
Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment OSB/DPS OCE/DHC 1537 03/10/06
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional Questions OCE/DHC 1427 07/16/03
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Three Additional Questions; Final Guidance for Industry and FDA Staff OCE/DHC 1408 07/09/02
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Final Guidance for Industry and FDA Staff OCE/DHC 1333 07/06/01
Guidance on Medical Device Patient Labeling OCE/DHC 1128 04/19/01
Guidance for Industry - Wireless Medical Telemetry Risks and Recommendations 1173 09/27/00
Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management OCE/DHC 1497 07/18/00
FDA Modernization Act of 1997 - Guidance for the Device Industry on Implementation of Highest Priority Provisions OCE 434 02/06/98
Medical Device Reporting for Manufacturers OCE/DICE 987 03/01/97
Human Factors Points to Consider for IDE Devices OCE/DHC 839 01/17/97
Do It By Design - An Introduction to Human Factors in Medical Devices OCER/DHC 995 12/01/96
Medical Device Reporting for User Facilities (PDF Only) (PDF - 313KB) OCE/DHC 04/01/96
Certification Statement for the Impact Resistance Test (PDF Only) (PDF - 35KB) OCE/DICE 1460 10/25/93
Human Factors Principles for Medical Device Labeling (PDF Only) (PDF - 1.3MB) OCE/DHC 227 09/01/93
Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (PDF Only) (PDF - 3MB) OCE/DICE 470 09/01/89

Page Last Updated: 07/31/2015
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