Medical Devices

Office of Surveillance and Biometrics Final Guidance

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 For a list of current draft guidance documents, please see the Draft Guidance page.

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Office of Surveillance and Biometrics Final Guidance Documents

TitleOrganizationDoc #Date
Unique Device Identifier System: Frequently Asked Questions, Vol. 1 - Guidance for Industry and Food and Drug Administration Staff (PDF - 462KB) CDRH CBER 1400050 08/20/14
Unique Device Identification System: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff (PDF - 420KB) CDRH CBER 1400046 08/13/14
Global Unique Device Identification Database (GUDID) - Guidance for Industry and Food and Drug Administration Staff (PDF - 2.8MB) CDRH/OSB CBER 1831 06/27/14
Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff OSB/DPS 1679 02/14/14
Procedures for Handling Post-Approval Studies Imposed by PMA Order OSB/DPS 1561 06/16/09
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests OSB/DB 1620 03/13/07
Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials OSB/DB 1601 02/05/10
Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act OSB 316 04/26/06
Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment OSB/DPS OCE/DHC 1537 03/10/06
Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers OSB/DSS/RSMB 250 11/12/02
Medical Device Reporting - Remedial Action Exemption; Guidance for FDA and Industry OSB/DSS/RSMB 188 09/26/01
Hospital Reprocessors: Guidance on Adverse Event Reporting for Hospitals that Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use OSB/DSS/RSMB 1334 04/24/01
MEDWATCH Medical Device Reporting Code Instructions OSB/DSS 853 04/04/01
Medical Device Reporting - Alternative Summary Reporting (ASR) Program OSB/DSS/RSMB 315 10/19/00
Guidance for Industry and for FDA Reviewers/Staff - Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements OSB/DPS 946 02/02/00
SMDA to FDAMA: Guidance on FDA’s Transition Plan for Existing Postmarket Surveillance Protocols OSB/DPS 318 11/02/98
Variance from Manufacturer Report Number Format - No. 5 OSB/DSS 08/12/96
MDR Guidance Document No. 1 - IOL - E1996004 OSB/DSS 216 08/06/96
Variance from Manufacturer Report Number Format [MDR letter] OSB/DSS 1059 07/16/96
Medical Device Reporting: An Overview (PDF - 105KB) OSB/DSS 509 04/01/96
Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices OSB 476 01/01/96
MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF) (PDF - 2.7MB) 10/01/15
Common Problems: Baseline Reports and MedWatch Form 3500A (letter to manufacturers updated)(PDF version) (PDF - 210KB) OSB/DSS 379
Perspectives on Clinical Studies for Medical Device Submissions (PDF Only) (PDF - 468KB) OSB 78
PMA Review Statistical Checklist (PDF Only) (PDF - 69KB) OSB 84 01/01/97

Page Last Updated: 11/26/2014
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