MDR Guidelines

How & When To Report Medical Device Problems To The FDA

The FDA came into being in 1906 with the passage of the 1906 “Pure Food and Drugs Act.” The primary mission of the FDA when it was created was to reduce the many serious abuses in the consumer product marketplace. Earlier that year Upton Sinclair’s book “The Jungle" was published. The book graphically exposed the many unsanitary conditions in the meatpacking business. The public uproar created by Sinclair’s book pushed Congress to pass the legislation.

Over the past 113 years the primary mission of the FDA has evolved into a greatly expanded role. Specifically “The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods & feed and veterinary products.”1

When it comes to the FDA’s role in protecting the public from dangerous, harmful medical devices, the FDA relies on several programs including pre-market approval of devices through the 510(k) approval process. Once medical devices are approved and in the market, the FDA relies on the Medical Device Reporting (MDR) system to detect problems and issues. MDRs are used to monitor the performance of devices in the marketplace and to detect potential device-related safety issues. MDRs are also used by the FDA, the CDC and ECRI to do risk vs benefit assessments of medical devices that are in daily use.

The FDA requires manufacturers, device user facilities (i.e. healthcare facilities) and importers to submit certain types of reports for adverse events and product problems with medical devices to the FDA. The FDA also encourages the submission of reports voluntarily by patients, consumers, caregivers and health care professionals about serious adverse problems associated with a medical device along with product quality issues and failures. The FDA uses these MDR reports to improve patient safety. 2

It is vital that healthcare facilities comply with the Medical Device Reporting (MDR) regulation (21 CFR Part 803). This federal regulation contains mandatory requirements for user facilities to report device-related adverse events and product problems to the FDA and the manufacturer of the device.

According to the FDA, “A ‘device user facility’ is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.” 3,4

FDA Form 3500A must be filled out and submitted within ten working days from the time that any medical personnel in your healthcare facility becomes aware of a reportable event. The form can be downloaded at www.fda.gov and submitted to the FDA electronically. Please remember that the completed Form 3500A that details the death or serious injury of a patient must be submitted to both the FDA and to the medical device manufacturer.

If a medical device malfunctions or fails to operate/perform properly, you and/or your healthcare facility can voluntarily report the issue to the FDA.

A user facility is not required to report a device malfunction, but can voluntarily advise the FDA of such product problems using the voluntary MedWatch Form FDA 3500 under the FDA’s Safety Information and Adverse Event Reporting Program. Healthcare professionals within a user facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA (See ‘Medical Device Reporting for User Facilities’, a guidance document issued by the FDA).” 5

FDA Form 3500 for voluntary reporting can be downloaded at www.fda.gov and submitted to the FDA electronically. In addition to filing the reports electronically, Form 3500A and 3500 can be filed manually by sending them to:

FDA Center for Devices and Radiological Health Medical Device Reporting, P.O. Box 3002 Rockville, MD 20847-3002

Helping the FDA fulfill its job in protecting the public is everyone’s responsibility.

  1. https://www.fda.gov/
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  4. FDA publication “Medical Device Reporting for User Facilities” April, 1996
  5. https://www.fda.gov/