- Overview of Medical Device Reporting
- Mandatory Medical Device Reporting Requirements
- Voluntary Malfunction Summary Reporting Program
- Voluntary Medical Device Reporting
- How to Report a Medical Device Problem
- Submitting Medical Device Reports for Devices Licensed as Biological Products
- Searching Medical Device Reports
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 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):
- Any reportable malfunction associated with a 5-day report under § 803.53(a).
- If a device is the subject of a recall reportable under 21 CFR Part 806 to address a malfunction, any reportable malfunction of the same nature that involves the same or similar device marketed by the manufacturer must be submitted as an individual report until the recall is terminated.
- The FDA has determined that individual MDR reporting is necessary to address a public health issue for certain devices. Examples of situations where the FDA has determined that individual reporting is necessary to address a public health issue include:
- Where the device was reusable and represented a high risk of infection if not adequately reprocessed. Appendix E of the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance," identifies device types associated with such risks.
- Where there was a high level of uncertainty regarding device risk.
- Where malfunction events were potentially attributed to complex failure modes and root causes were not well understood.
- Where there were ongoing signals or other safety-related investigations for the device.
These are examples of situations where individual malfunction reporting data are needed in place of summary information to understand malfunction events and the causes of those events. Public health issues may involve a specific individual device or multiple devices (for example, all devices of the same type).
- The FDA has determined that a specific manufacturer is no longer allowed to participate in the program. Examples of situations where this may occur include:
- Where there has been a failure to comply with applicable MDR requirements under 21 CFR Part 803 or a failure to follow the conditions of the VMSR program.
- Where there is a need to monitor a public health issue, such as a safety-related investigation involving the specific manufacturer.
- The reportable malfunction is a new type of malfunction that the manufacturer has not previously reported to the FDA for that device.
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 [email protected], with the following information:
- The firm's name, address, registration number
- The contact person's name, telephone number, and email address
- Complete device identification and description, including product code and review panel
- A complete statement of the request and rationale for the request, including actions taken to address any issues noted in prior FDA correspondence regarding device eligibility, if any
- As part of the justification for the request, it is helpful to provide a copy of any prior FDA correspondence regarding device eligibility status
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).
Mandatory Reporting for Manufacturers, Importers and Device User Facilities (Form FDA 3500A):
Find information and instructions for mandatory device reporting at:
- Reporting Medical Device Adverse Events for Manufacturers, Importers and Device User Facilities
- Instructions on Voluntary Malfunction Summary Reporting Program
- Instructions for Completing Form FDA 3500A
- eMDR - Electronic Medical Device Reporting
- Medical Device Reporting for Manufacturers - Guidance for Industry and Food and Drug Administration Staff
- FDA Guidance: Medical Device Reporting for User Facilities (PDF Only) (PDF - 313KB)
For Questions about Medical Device Reporting, including interpretation of MDR policy:
- Call: (301) 796-6670
- Email: [email protected]
- Or write to:
Food and Drug Administration
Center for Devices and Radiological Health
MDR Policy Branch
10903 New Hampshire Avenue
WO Bldg. 66, Room 3217
Silver Spring, MD 20993-0002
Voluntary MedWatch Reporting for Patients, Health Professionals and Consumers (Form FDA 3500):
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:
- Complete the MedWatch Online Reporting Form
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
To Report an Emergency
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
- Voice (24hr/day) phone: 866-300-4374 or 301-796-8240
- FAX: 301-847-8543
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.
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence 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 this, MDRs comprise only one of the FDA's several important postmarket surveillance data sources.
June 21, 2019: In the spirit of promoting public transparency, the FDA is making Alternative Summary Reporting (ASR) data available to the public on the MDR Data Files page. These data files include ASRs submitted to the FDA between 1999 and April 2019.
In 2017, the FDA began to sunset the ASR Program and requiring manufacturers with ASR exemptions to submit, in addition to the spreadsheet, a companion report that includes the total number of events being summarized. The companion reports are available in the public MAUDE database and represent a subset of the events in the ASR spreadsheets posted 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) by telephone at (301) 796-7100, or by email at [email protected].
- MedWatch: The FDA's system for voluntary reporting
- MDR Database Search: This database captures MDRs that were received prior to July 31, 1996
- Device Advice: Regulatory Assistance for Industry on Mandatory Reporting and Regulation History
- Electronic Medical Device Reporting
- CDRH Learn with Medical Device Reporting
- Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices