The new article addresses the aspects related to the scope of events eligible for the program, as well as to its general conditions.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to the Voluntary Malfunction Summary Reporting (VMSR) Program introduced in order to reduce the regulatory burden and ensure proper allocation of the authority’s review resources. Once finalized, the document will provide an overview of the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the respective legislation and has been agreed with the authority in advance.
The scope of the guidance covers, inter alia, the aspects related to the event types falling outside the scope of the program, as well as its main conditions.
As it was mentioned before, under the VMSR Program, some of the adverse events associated with medical devices allowed for marketing and use in the US could be reflected in quarterly reports instead of being reported separately. In order to assist the parties responsible for medical devices in understanding the scope of events subject to reporting under the VMSR Program, the authority indicates the ones that are not eligible and, consequently, should be reported in accordance with the general rules and requirements on medical device reporting (MDR). According to the guidance, the Program will not be applicable in the case of:
- Reportable serious injuries;
- A reportable malfunction associated with a 5-day report, as required in 21 CFR 803.53; and
- Importers and device user facilities, because 21 CFR Part 803 does not require either entity to report malfunctions to FDA.
Individual Reporting Conditions: Key Points
The document further provides an overview of the VMSR Program Conditions including, inter alia, individual reporting conditions. According to the guidance, when determining certain product codes to be eligible, the authority may impose additional conditions and requirements in order to ensure public health protection. These conditions should be followed by medical device manufacturers participating in the VMSR Program and include conditions for “individual reporting”, submission of supplemental reports, and the format and submission schedule for summary reports. Furthermore, it is also stated that in certain cases, individual reporting will still be necessary even with respect to the eligible product codes, while medical device manufacturers will be responsible for identifying whether these special conditions apply. Apart from this, the authority may also notify the parties responsible for medical devices about cases when individual reporting is required, explain the grounds for this, and describe the particular steps to be taken.
According to the guidance, medical device manufacturers participating in the VMSR Program are obliged to submit individual reports in the following cases:
- Reportable malfunction is associated with a 5-day report. In accordance with the applicable regulatory requirement, a 5-day report should be submitted by the medical device manufacturer, should it become aware of the incident that required additional actions to be taken in order to prevent an unreasonable risk of substantial harm to the public health. Once such a report is submitted, all subsequent reports should be submitted individually as well in accordance with the respective regulatory requirements, unless the authority informs a party responsible for a medical device that the issue has been resolved and no further actions are needed. However, information about these events could also be included in summary reports submitted under the Program. As explained by the FDA, the main purpose of 5-day reports is to ensure the authority is duly notified about any and all adverse events that require special attention and monitoring in order to prevent harm caused to public health.
- A reportable malfunction is the subject of certain device recalls. According to the notice published by the FDA, individual reports should also be submitted in cases when the device in question is subject to a recall, corrective actions, or removal from the market. In such cases, the reports related to all reportable events should be submitted individually in accordance with the respective regulatory requirements, unless a recall is terminated by the authority. It is also stated that upon the termination of a recall, summary reporting under the VMSR Program could be continued, except the situations when the authority decides to revoke the VMSR Program alternative after a recall. The document also mentions that if a manufacturer becomes aware of reportable malfunction events before the date that the requirement to submit individual reports is triggered and summary report for those events has not yet been submitted to FDA, then the manufacturer must submit any of those malfunction events related to the recall in a summary MDR format within 30 calendar days of submitting the required report of correction or removal. The appropriate checkbox is also included in the summary MDR form.
In summary, the present FDA guidance outlines the scope of incidents and adverse events that are not eligible for the VMSR Program and also describes the cases when individual reports are still required even if the product codes are eligible for the Program. The document also specifies additional conditions the authority may impose in order to ensure public health protection.
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