Medwatch Medical Device Reporting

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

Submit reports to the FDA through the MedWatch program in one of the following ways: Complete the MedWatch Online Reporting Form. Download form or call 1-800-332-1088 …

MedWatch: FDA Safety Information & Adverse Event …

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional …

MedWatch Forms for FDA Safety Reporting | FDA

https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting

Instructions for Completing Form FDA 3500 | FDA

https://www.fda.gov/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-3500

If the case report involves more than one (1) suspect medical device, please prepare a complete copy of Form FDA 3500 that identifies one device and attach an …

Reporting Serious Problems to FDA | FDA

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda

A consumer-friendly version of the 3500 reporting form. Form FDA 3500B for Consumer Reporting (pdf) Industry (Mandatory) Reporting by IND reporters, manufacturers, …

Coding Resources for Medical Device Reports | FDA

https://www.fda.gov/medical-devices/mdr-adverse-event-codes/coding-resources-medical-device-reports

This page contains a comprehensive set of resources for reporters to use when selecting event codes in a Medical Device Report (MDR) and contains information …

MDR Adverse Event Codes | FDA

https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes

The FDA Medical Device Report (MDR) adverse event codes are collectively a system of codes, terms, and definitions used to describe and categorize medical device adverse …

eCFR :: 21 CFR Part 803 -- Medical Device Reporting

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803

You must submit your annual report to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002. Your annual report must include: ( 1) Your CMS …

MedWatch: The FDA safety information and …

https://www.rimsys.io/blog/medwatch-the-fda-safety-information-and-adverse-event-reporting-program

The MedWatch program is an FDA program designed to collect voluntary reports of adverse reactions and quality problems of drugs and medical devices, along with all …