Electronic Medical Device Reporting

FDA Guidance

Questions and Answers about eMDR – Electronic Medical
Device Reporting

eMDR – Electronic Medical Device Reporting

On Feb. 13, 2014, the FDA published a final rule on Electronic Medical Device Reporting (eMDR), dated 2014-02-14, that requires manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive. The two options for submitting eMDRs are: eSubmitter or Health Level 7 Individual Case Safety Reports (HL7 ICSR), which are described below. Both options are open to all reporters. User facilities can also submit eMDR reports following one of these options, but the final rule allows user facilities to continue to submit paper MDR reports. Manufacturers and importers will have until Aug. 13, 2015 to begin submitting all MDR reports electronically. If you are unable to meet this date, you must request and obtain an exemption from electronic reporting to continue to report via hardcopy past Aug. 13, 2015.

The FDA also released a Guidance for Industry, User Facilities and FDA Staff “Questions and Answers about eMDR- Electronic Medical Device Reporting” to answer questions related to FDA’s final rule requiring device manufacturers and importers to submit mandatory MDRs electronically.

What is Medical Device Reporting (MDR)?

The Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers and user facilities to report significant medical device adverse events to the Food and Drug Administration (FDA). FDA uses this information to identify and respond to problems associated with medical devices.

There is also a voluntary MedWatch program for consumers or healthcare professionals to use to voluntarily report significant adverse events or product problems with medical products to FDA.

Medical Device Reporting (MDR) Mandatory Reporting Requirements

Manufacturers

Manufacturers are required to report to FDA when they learn one of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to FDA when they become aware that one of their devices has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction happened again.

Importers

Importers are required to report to 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 when they become aware that one of their devices has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to happen again.

[pullquote align=”left”]

Medical Device Safety

  • How to Report a Medical Device Problem
  • Event Problem Codes
  • Manufacturer Evaluation Codes

[/pullquote] User Facilities: User Facilities (e.g., hospitals, nursing homes) are required to report a suspected medical device-related death to both the FDA and the manufacturer. User facilities should report a medical device-related serious injury only to the manufacturer. If the medical device manufacturer is unknown, the user facility should report the serious injury to FDA. A user facility is not required by the MDR regulation to report a malfunction, but can use the voluntary MedWatch program to advise FDA of problems with medical devices. Health-care 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 FDA.

Voluntary MDR Reporting

Consumers and/or health-care professionals should visit the MedWatch: The FDA Safety Information and Adverse Event Reporting Program for instructions on how to report significant adverse events or problems with medical products.

History of MDR Regulation

Legislation requiring device user facility reporting was enacted by Congress to increase the amount of information the Food and Drug Administration (FDA) and device manufacturers receive about problems with medical devices. Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous reports have shown there is widespread underreporting. A 1986 General Accounting Office (GAO) study showed that less than one percent of device problems occurring in hospitals are reported to FDA, and the more serious the problem with a device, the less likely it was to be reported. A GAO followup study in 1989 concluded that despite full implementation of the Medical Device Reporting (MDR) regulation, serious shortcomings still existed.

Under the Safe Medical Devices Act of 1990 (SMDA), device user facilities must report device-related deaths to the FDA and the manufacturer, if known. Device user facilities must also report device-related serious injuries to the manufacturer, or to the FDA if the manufacturer is not known. In addition, SMDA also required that device user facilities submit to FDA, on a semiannual basis, a summary of all reports submitted during that time period. The device user facility reporting section of SMDA became effective on November 28, 1991.

To implement SMDA, FDA published a tentative final rule in the Federal Register on November 26, 1991, and invited comments on the regulation. Over 300 comments were received by FDA. Then, on June 16, 1992, the President signed into law the Medical Devices Amendments of 1992 (Public Law 102-300; the Amendments of 1992), amending certain provisions (section 519 of the Food, Drug, and Cosmetic Act) relating to reporting of adverse events. The primary impact of the 1992 Amendments on device user facility reporting was to clarify certain terms and to establish a single reporting standard for device user facilities, manufacturers, importers, and distributors. A final rule published in the Federal Register on December 11, 1995, addresses the comments received by the FDA and the changes mandated by the Amendments of 1992.

Update on FDAMA

The Food and Drug Administration Modernization Act (FDAMA) was signed on 11/21/97 and became effective on 2/19/98. There were four changes that affected MDR:

  • Manufacturers and distributors/importers do not need to submit annual certification.
  • Domestic distributors are no longer required to file MDR reports, but must continue to maintain complaint files. [Importers (initial distributors for devices manufactured overseas and imported into the USA) must continue to file MDR reports.]
  • User facilities must now file an annual report instead of semiannual reports to summarize their adverse event reports.
  • Sentinel reporting by user facilities was proposed.
    The MDR regulation was revised on 1/26/2000 and 5/8/2000 to incorporate the changes under FDAMA

See the nearby link to amendments to the MDR regulation that implemented FDAMA changes, effective March 27, 2000.

Databases

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Last Updated: 2015-07-26