The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device reporting requirements. The document is intended to provide additional clarifications regarding existing regulatory requirements on adverse event reporting the medical device manufacturers should follow as a part of their post-market obligations. In particular, the guidance covers the matters related to the completion of the MDR report. It is important to mention that FDA guidance documents are non-binding and are not intended to introduce new rules and obligations. Moreover, an alternative approach could be applied, provided such an approach complies with existing regulatory requirements and has been agreed with the authority in advance.
Table of Contents
General Questions
As it was mentioned before, the document is intended to provide additional recommendations regarding the way the medical device reporting form should be completed by a party responsible for submitting a report. At the same time, the authority explicitly emphasizes that in case of any discrepancies with instructions for completing the form published before the latter should prevail. In terms of information to be included in the report, the document refers to regulation 21 CFR 803.52. As prescribed by the applicable regulation, a medical device report should be filed to the authority in an electronic format, except the cases when exemptions are applicable.
In terms of general recommendations, the FDA states that all fields of the form should be filled, otherwise it would be unclear for the authority whether the information is missing.
Information to be Provided
The guidance also provides additional clarifications regarding the scope of information to be included in adverse event reports. In particular, the guidance describes in detail the way this information should be provided depending on specific cases. For instance, the document provides the following recommendations:
- As it was mentioned before, the name of the patient should be replaced with a code to prevent identification. Moreover, in case the patient is a reporter as well, it should not be indicated in the report. At the same time, there should be no blank fields, as the authority will treat this as a failure of the submitter to provide the data requested.
- When providing information about the incident itself, the submitter is encouraged to provide all the details available including: (i) how the device was involved; (ii) the nature of the problem; (iii) the required patient treatment; (iv) the patient outcome or final condition; and (v) any environmental conditions that may have influenced the event.
- Should the manufacturer initially receive information from a healthcare facility, it should be also reflected in the report, together with the details of the facility, while its report could be attached to the submission? The authority also reserves the right to request additional information about the healthcare facility, should it find the information provided incomplete.
- Another important element to be provided is the “evaluation codes” used by the manufacturer to provide additional information regarding the actions taken concerning an event, including the details on (1) method used to evaluate the medical device involved in the reported event; (2) Results of the evaluation; and (3) conclusions made concerning the relationship of the device to the reported event. As further explained by the FDA, the codes could be divided into two main categories: the ones describing the device subject to evaluation (where it derives from), and the ones indicating the particular evaluation undertaken. The first type is used to provide references to the source the device is taken from (e.g., the same lot as the device in question); while the second type indicates the particular sphere where the problem has been identified (e.g., the device itself, the way it has been used, or general factors related to the procedure or physiological matters). Separate categories are used to indicate the issues associated with specific components of the device, or computing elements (i.e., computers, imaging systems, and microprocessors). Once the evaluation is completed, the manufacturer should duly assign at least one corresponding code. The authority also mentions that the manufacturer should indicate evaluation (conclusion) codes even if there was no actual evaluation – according to the guidance, in such a case, the codes should be assigned based on information available to the manufacturer. As in the case with other fields, this field should not remain blank.
- A specific approach should be applied to corrections taken by the manufacturer in response to the adverse event. According to the guidance, if the scope of correction performed covered only the device in question, this would not be subject to reporting. At the same time, additional information should be provided by the manufacturer in case of correction or removal initiated to (1) reduce a risk to health posed by the device, or (2) remedy a violation of the FD&C Act caused by the device which may present a health risk. As explained by the FDA, such actions should be reported within 10 business days from the date they were initiated. In such cases, the manufacturer should submit the report of correction and removal as a part of the general report. Should it be necessary to submit a report before deciding corrective actions, additional information should be provided within one month from the date such a decision will be taken. However, if the reporting entity is not the one that is entitled to initiate corrective actions, the appropriate fields should remain blank.
Basic Requirements for Third Parties
Apart from specific aspects described hereinabove, the guidance also provides additional clarifications regarding the applicable requirements for various parties which are involved in operations with medical devices and, consequently, are subject to reporting requirements, including healthcare facilities, importers, and distributors.
According to the guidance, healthcare facilities are obliged to report adverse events that meet the reporting criteria within 10 business days from the date they reasonably become aware of an incident. Depending on the severity of the consequences, an incident should be reported either to the medical device manufacturer only or to both manufacturer and the authority. Furthermore, healthcare institutions are also obliged to:
- Keep records of all the adverse events reported during the year and submit the appropriate summary on an annual basis;
- Develop, maintain and implement written MDR procedures; and
- Maintain files related to medical device adverse events.
Under existing legislation, an importer stands for any person who imports a device into the US and who furthers the marketing of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user of the device. As prescribed by the applicable regulations, importers are obliged to submit reports regarding reportable events within 30 calendar days from the date they occur.
In summary, the present FDA guidance provides additional clarifications regarding the information to be included in a medical device report. The document highlights the most important aspects to be considered concerning the way the details should be provided.
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