What are the federal requirements for reporting adverse events related to medical devices?
Under the Medical Device Reporting (MDR) regulation, 21 CFR 803, device user facilities are required to report certain device-related adverse events and product problems to the U.S. Food and Drug Administration (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.
Medical device reporting requirements for user facilities (21 C.F.R. § 803.30(a)(1)) are as follows:
- Device-related adverse events and product problems must be reported as soon as practicable, but no more than 10 working days after the day a user facility becomes aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to the death of a patient of that facility. The facility must also submit the report to the device manufacturer, if known. The information reported should include all information required by 803.32 on FDA Form 3500A or an electronic equivalent approved under 803.14.
- A user facility must submit a report to the manufacturer of the device no later than 10 work days after the day that it becomes aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of the facility. If the manufacturer is not known, the facility must submit the report to the FDA. The information reported should include all information required by 803.32 on FDA Form 3500A or an electronic equivalent approved under 803.14.
“Reasonably known” information includes all of the data elements listed in 21 CFR 803.32. This includes information found in documents that the facility possesses and any information that becomes available as a results of the follow-up within the facility.
FDA Medical Device Reporting, page last updated July 16, 2015
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