FDA Reporting Systems Overview

MDR (Medical Device Reporting)

Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. MDR includes reports to FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. MDR is required to satisfy the requirements of 21 CFR Part 803.


MedWatch

MedWatch is the Food and Drug Administration’s Safety Information and Adverse Event Reporting Program. MedWatch is used for reporting an adverse event or sentinel event. Founded in 1993, this system of voluntary reporting allows such information to be shared with the medical community or the general public. The system includes publicly available databases and online analysis tools for professionals. MedWatch also disseminates medical product safety alerts – such as recalls and other clinical safety communications.

Education and Training Links:

FDA MedWatch Webinar: The FDA hosted a webinar “FDA’s MedWatch System: How to Report Adverse Events”, Thursday, October 20th at 11:00 AM ET. The featured speaker, Brenda Rose Pharm.D., a Health Programs Coordinator in FDA’s Office of Special Health Issues will gave an overview and answered questions about how to report adverse events to MedWatch.

Webinar Slides: MedWatch Presentation

MedWatch Form 3500: http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/UCM082725.pdf

FDA’s MedWatch Program: Voluntarily Reporting Problems to the FDA: The FDA hosted a webinar “FDA’s MedWatch Program: Voluntarily Reporting Problems to the FDA”.

The featured speaker, Cristina Whalen Klafehn, Pharm.D, BCPS, a Health Programs Coordinator in FDA’s Office of Health and Constituent Affairs gave an overview and answered questions about how to report adverse events to MedWatch.

Webinar slides: FDA’s MedWatch Program: Voluntarily Reporting Problems to the FDA (PDF – 2.48MB)

Recorded webinar: https://collaboration.fda.gov/p7m0a8eo69d/

Additional Resources


MedSun: Shining a Light on Medical Product Safety

The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002 by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). The primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.

Education and Training Links:

Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software

Presentation by John F. Murray Jr., Software Compliance Expert, US Food and Drug Administration: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm127922.htm

MedSun OR Educational Training Program Medical Devices: “Improving Patient Safety by Reporting Problems with Medical Devices”

Instructor Guide and Script – Operating Room Version

http://www.fda.gov/downloads/medicaldevices/safety/medsunmedicalproductsafetynetwork/ucm171906.pdf

Additional Resources:

MedSun Educational Training Program PDF: “Improving Patient Safety by Reporting Problems with In Vitro Diagnostic Devices” Instructor Guide and Script

http://www.fda.gov/downloads/medicaldevices/safety/medsunmedicalproductsafetynetwork/ucm127961.pdf

MedSun Educational Training Program PDF: “Improving Patient Safety by Reporting Problems with Medical Devices” Instructor Guide and Script General Version

http://www.fda.gov/downloads/medicaldevices/safety/medsunmedicalproductsafetynetwork/ucm127955.pdf


MAUDE

(Manufacturer and User Facility Device Experience) database

The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

Education and Training Links: