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Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. 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.
Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.
The FDA reviews all medical device reports (MDRs) received. The FDA’s analysis of MDRs evaluates the totality of information provided in the initial MDR as well as any MDR supplemental reports subsequently provided. The submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. For example, in certain MDRs, the text of the report may include the word “death” or a related term. However, the MDR would not, and should not, be classified as death unless the reporter believes the patient’s cause of death was or may have been attributed to the device or the device was or may have been a factor in the death.
In addition, although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of these limitations, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources.
The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Device User Facilities: 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.
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.
Visit Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities for specifics on requirements and associated processes.
Medical Device Reports for Devices Licensed as Biological Products: For instructions for mandatory medical device reporting for licensed medical devices regulated as biological products by the Center for Biologics Evaluation and Research (CBER), see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products.
The Voluntary Malfunction Summary Reporting (VMSR) program was established in 2018 and permits manufacturers to report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. It reflects a pilot program conducted in response to changes made by Section 227 of the Food and Drug Administration Amendments Act of 2007 and the goals for streamlining malfunction reporting outlined in the commitment letter agreed to by the FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter. The FDA believes the program will enhance the FDA’s capacity to effectively monitor many devices.
In the Federal Register of December 26, 2017 (82 FR 60922), the FDA issued a notification outlining the FDA’s proposal to grant an alternative under 21 CFR 803.19 to permit reporting by a manufacturer of certain device malfunctions in summary form on a quarterly basis, subject to certain conditions, and requested comments from the public. On August 17, 2018, (83 FR 40973) the FDA issued a notification granting this alternative and describing the overarching principles for the VMSR program. Key among these principles is transparency of this information to the FDA and to the public, regardless of whether the information is reported as an individual Medical Device Report (MDR) or VMSR.
Under the VMSR program, manufacturers submit separate summary reports for each unique combination of brand name, device model, and problem code(s). Each summary report identifies the total number of reportable malfunctions, and the summary reports are available to the public in MAUDE. Importantly, mandatory submission of individual reports of death or serious injury events continues to be required, under sections 803.50 and 803.52, or 803.53, as applicable.
VMSR Eligibility: Devices, manufacturers, or specific kinds of reportable device malfunctions are not eligible for VMSR in the following situations, as stated in the Federal Register on August 17, 2018 (83 FR 40973):
In addition, as stated in the Federal Register notice, the FDA does not intend to consider devices under product codes in existence for less than 2 years to be eligible for the program, unless the new product code was issued solely for administrative reasons. The FDA periodically assesses the eligibility of product codes for the VMSR program.
Eligibility Status: The status of a given device product code for summary reporting under the VMSR program is listed in the CDRH Product Classification Database.
Eligibility Requests: If a manufacturer would like to request, under 21 CFR 803.19(b), that the FDA consider whether a given device product code should be eligible for the VMSR program, they can email their request to MDRPolicy@fda.hhs.gov, with the following information:
The FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems with medical products to MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.
Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers).
Find information and instructions for mandatory device reporting at:
For Questions about Medical Device Reporting, including interpretation of MDR policy:
Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Submit reports to the FDA through the MedWatch program in one of the following ways:
If you have identified a public health emergency, you may use the following contact information to alert the FDA:
FDA Office of Crisis Management, Emergency Operations Center
While most medical devices subject to the FDA’s oversight are regulated by the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) is also responsible for the regulation of certain medical devices.
Currently, CBER is designated the lead center in the FDA for regulating in vitro diagnostic (IVD) medical devices intended for screening or confirmatory clinical laboratory testing associated with blood banking practices and other process testing procedures. For more information unique to IVDs, see Overview of IVD Regulation.
IVD devices licensed as biological products are also subject to the applicable regulations under 21 CFR Part 803 – Medical Device Reporting. For instructions for medical device reporting for devices regulated as biological products by CBER, see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products.
The Manufacturer and User Facility Device Experience (MAUDE) database contains mandatory reports filed by manufacturers and importers from August 1996 to present, all mandatory user facility reports from 1991 to present, and voluntary reports filed after June 1993. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
There are certain cases in which such information was not included in MAUDE. Older reports received through CDRH’s legacy Device Experience Network (DEN) reporting system from 1984 – 1996 and reports received under the Alternative Summary Reporting Program from 1999 – April 2019 are not available in MAUDE. In the spirit of promoting public transparency, the FDA posted Alternative Summary Reporting (ASR) data and Device Experience Network (DEN) reports on the MDR Data Files page.
Individuals are also able to request information related to Medical Device Reports by submitting a Freedom of Information Act (FOIA) request either in writing or online.
For general questions, please contact the Division of Industry and Consumer Education (DICE).
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