The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document on medical device reporting. The document addresses the most important aspects related to the reports to be submitted by responsible entities with regard to incidents and adverse events associated with medical devices placed on the US market.
The guidance provides additional clarifications and recommendations to be considered by all the parties involved in operations with medical devices. Due to the legal nature of the document, the recommendations provided therein are non-binding. Additionally, the Agency emphasizes that an alternative approach could be applied, provided such an approach complies with the applicable regulatory requirements. First, the document describes the responsibilities of medical device manufacturers with regard to adverse event reporting.
According to the document, in certain cases, an event that formally falls within the scope of a reportable event does not have to be reported. Under the general rule, a medical device manufacturer shall conduct an investigation of any and all complaints received with regard to medical devices for which it is responsible. It is stated that the requirement to submit a medical device report could be waived in the following cases:
- The manufacturer possesses information confirming that the medical device in question has not contributed to an adverse event, provided that it is determined by a qualified person (e.g., healthcare professional). In such a case, the manufacturer shall duly keep the information upon which such a decision is based.
- It was identified that the information received is incorrect, and the incident in question has not actually taken place.
- The device subject to review has been manufactured by another medical device manufacturer.
- The information about the same incident comes from multiple sources. In such a case, only one report should be submitted.
Should the medical device manufacturer decide not to submit a report due to the points listed above, the information supporting such a decision should be duly kept to be provided to the authority once requested. The period during which such information should be kept should be equal to two years from the incident date or during the whole period of the expected life of the product in question. If the decision not to submit a report is based on a conclusion that the medical device in question is manufactured by another manufacturer, the information associated with the incident should be provided to the FDA together with a detailed justification of the decision made.
Reporting Requirements for Contract Manufacturers
The guidance further describes specific reporting requirements to be applied in the case of contract manufacturers. In accordance with the applicable legislation, the current definition of a “manufacturer” used in the context of medical device reporting covers a firm that initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications. It is also stated that the medical device manufacturer that is not involved in the distribution of medical devices produced upon request and in accordance with specifications and requirements provided by another party is not subject to reporting obligations. At the same time, if both companies are involved in marketing the products in question, both companies should be subject to reporting obligations as well. However, the companies could reach an agreement regarding who is responsible for submitting reports related to the devices, exempting the other from responsibility. When applying for such an exemption, the companies should jointly describe how the medical device reports would be submitted and also provide additional information about any agreements concluded between the companies with regard to reporting obligations.
The authority especially emphasizes that the information related to the adverse events associated with medical devices manufactured and distributed in the way described above should be duly kept by both companies. The necessary precondition of such an exemption to be granted by the FDA is the implementation of the appropriate procedures ensuring the medical device report would be submitted in time. The Agency also mentions that if the company designated to be responsible for reporting fails to comply with its obligations, the exemption granted to another company would be revoked. In such a case, both companies would have to submit reports in accordance with the general requirements.
Types of Reports
The applicable legislation prescribes three types of reports to be submitted by the entities responsible for medical devices, namely:
- 30-day (initial) reports [21 FR 803.10(c), 803.20 and 803.50];
- 5-day reports [21 CFR 803.10(c), 803.20 and 803.53];
- Supplemental reports [803.10(c) and 803.56].
Hence, the reports are classified depending on the applicable reporting period. The guidance further provides additional clarifications on each type of report.
According to the guidance, a “30-day report” is one to be initially submitted by a responsible entity within 30 calendar days of the date it becomes aware of an incident which falls under the reporting criteria. It is stated that the information such a report should contain 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.
Another type of report is a “5-day report” to be submitted by a responsible entity in case additional actions are required in order to mitigate the risks associated with the issue, or the submission of such a report is requested by the regulating authority. According to the guidance, calculation of such period starts from the day following the day the person having necessary qualification and knowledge to identify the risks to public health become aware of the event. At the same time, if submission of this report is requested by the authority, the report should be submitted in 5 days from the date any of the employees become aware of the incident.
As stated in the guidance, a supplemental (also referred to as a “follow-up”) report should be submitted if the responsible entity becomes aware of information that was not available when previous reports were submitted. According to the document, such a report would be required if newly obtained information impacts the initial conclusions made in the reports earlier submitted to the FDA. Under the applicable requirements, a supplemental report should be submitted within 30 calendar days from the date such information was received by a responsible entity. It is also important to mention that a supplemental/follow-up report should be submitted in the electronic format irrespectively of the format used for the initial report.
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