The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
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.
As per FDA – MDR regulation, manufacturers are required to report to the FDA when they learn about MDR reportable events (that one of their devices may have caused or contributed to a death or serious injury or has malfunctioned and this device or similar device would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur).
Reporting requirements:
Manufacturers of medical devices are required to submit reports to FDA of a reportable death, serious injury, or device malfunction. A reportable death, serious injury, or malfunction is based on information a manufacturer receives or otherwise becomes aware of, from any source, which reasonably suggests that one of its marketed devices:
- May have caused or contributed to a death or serious injury; or
- Malfunctioned and the malfunction of the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Summary of Mandatory Reporting Requirements for Manufacturers:
MDR reportable events aware date:
A manufacturer becomes ‘aware’ of an event whenever:
- Any of their employees become aware of information that reasonably suggests that an event is required to be reported in a 30-day report or in a 5-day report that the FDA request from manufacturer; or
- Any of their employees with management or supervisory responsibilities over persons with regulatory, scientific or technical responsibilities (including consultants or contractors) or whose duties relate to the collection and reporting of adverse events, becomes aware from any information (including any trend analysis) that an MDR reportable event(s) necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.
MDR reportable events – serious injury: As per 21 CFR 803.3, A “serious injury” is an injury or illness that,
- Is life threatening;
- Results in permanent impairment of a body function or permanent damage to a body structure; or
- Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
- a life-threatening injury meets the definition of serious injury, regardless of whether the threat was “temporary
MDR reportable events – Malfunction:
“Malfunction” means the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device.
A malfunction is reportable if any one of the following is true:
- The chance of a death or serious injury occurring as a result of a recurrence of the malfunction is not remote;
- The consequences of the malfunction affect the device in a catastrophic manner that may lead to a death or serious injury;
- The malfunction results in the failure of the device to perform its essential function and compromises the device’s therapeutic, monitoring or diagnostic effectiveness, which could cause or contribute to a death or serious injury or other significant adverse device experiences required by regulation. (The essential function of a device refers not only to the device’s labeled use, but also to any use widely prescribed within the practice of medicine.);
The malfunction involves:
- a long-term implant or
- a device that is considered to be life-supporting or life-sustaining and thus is essential to maintaining human life; or
- The manufacturer takes, or would be required to take an action under section 518 or 519(g)10 of the FD&C Act as a result of the malfunction of the device or other similar devices.
MDR non reportable events:
- Manufacturer have information that would enable a person who is qualified to make a medical judgment to reasonably conclude that their device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury, if it were to recur. Persons qualified to make a medical judgment include physicians, nurses, risk managers, and biomedical engineers.
- Manufacturer determine that the information that they received is erroneous in that a device-related adverse event did not occur.
- Device not manufactured by the company
- Information received from multiple sources regarding the same patient and the same event. One report is required for the event when first reported and information from other sources may require the submission of a supplemental report to the initial MDR report.
Manufacturer should retain documentation of erroneous complaints and conclusion that an event is not an MDR reportable event in MDR files for two years from the date of the event or a period equivalent to the expected life of the device, whichever is greater.
30 -day reports:
A “30-day report” is the initial MDR report that must be submitted within 30 calendar days after the day manufacturer become aware of a reportable device-related death or serious injury, or a reportable malfunction. Information that must be provided in initial report includes:
- Patient information;
- Information about the adverse event or device problem;
- Device information;
- Initial reporter information;
- Reporting information, including manufacturer contact information, and the report sources, date, type, and number; and
- Other information about the device and event [device manufacturer information.
5-Day Reports and Remedial Action
A “5-day report” (or five-day report) is a report that must be submitted to FDA within five work days after the day manufacturer become aware of an MDR reportable event:
• That necessitates remedial action to prevent an unreasonable risk of substantial harm to public health; or
• For which FDA have made a written request for the submission of 5-day reports
- A “remedial action” is any action, other than routine maintenance or servicing of a device, necessary to prevent recurrence of an MDR reportable event. FDA does not consider an action taken to correct only a single device involved in an MDR reportable event to be a remedial action.
- Not all MDR reportable events requiring remedial actions need to be submitted as 5-day reports. Only events that require remedial actions to prevent an unreasonable risk of substantial harm to the public health or events for which FDA requests such a report must be submitted as 5-day reports.
- When the remedial action taken is not required to address an unreasonable risk of substantial harm to the public health the reportable adverse events should be submitted as 30-day reports instead of 5-day reports.
Supplemental report:
A “supplemental” or “follow-up report” is a report that manufacturer submit whenever they obtain information required under 21 CFR 803.50 that was not known or available at the time of initial 30-day or 5-day report submission.
FDA consider a supplemental report to be required when new facts prompt manufacturer to alter or supplement any information or conclusions contained in the original MDR or in any prior supplemental reports.
The supplemental information must be submitted within one month (30 calendar days) following receipt of the information. Supplemental reports must be sent electronically even if the original report was submitted on paper.
Manufacturer must include:
- only the new, changed or corrected information in the appropriate portions of the respective forms for reports that cross reference previous reports.
- Indicate in the report being submitted that manufacturer submission is a “supplemental” or “follow-up” report; and
- List the appropriate identification number of the report that manufacturer are updating with the supplemental information (i.e., the manufacturer report number of the initial MDR).
MDRs from Outside the US (OUS)
- If a foreign event occurs, this chart specifies the MDR reporting obligation of the foreign event.
Exemption Request for Contract Manufacturer
- Any firm that initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications.
- A contract manufacturer who does not distribute or market the devices it manufacturers for a specifications developer would not have an MDR reporting obligation and would not require an exemption.
- If the contract manufacturer markets the devices that it manufacturers, then both the contract manufacturer and the specifications developer have MDR reporting obligations.
- If either the contract manufacturer or specifications developer wants to report on behalf of the other, an exemption is needed.
MDRs for IDE Situations
- If a device is legally marketed in the US and is also under an Investigational Device Exemption (IDE), any adverse event that involves the investigational use of the marketed device is subject to reporting under both the IDE regulation and the MDR regulation. (APPLIES TO NON-INVESTIGATIONAL DEVICE)
- If the device is under study it should be reported under the IDE only. (21 CFR Part 812) (APPLIES TO INVESTIGATIONAL DEVICE)
- If a marketed device is used as an investigational device (i.e. under a new indication for use), and if the adverse event results from the labeled marketed use of the device, it must be reported as an MDR.
- If the device is on the market in the US and is being studied under an IDE e.g. for a new indication, and the device is used outside of the IDE (either US or OUS) for the investigational indication (i.e., “off-label” use), and a complaint associated with this off-label use becomes known, then this complaint must be evaluated for reporting under § 803.
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