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The Food and Drug Administration (FDA or the Agency), the US authority in the sphere of healthcare products, has published a draft guidance document dedicated to the Voluntary Malfunction Summary Reporting (VMSR) Program intended to reduce the regulatory burden for the parties responsible for medical devices and ensure better allocation of review resources for the authority. In particular, the Program provides that information about certain adverse events associated with the eligible product codes could be included in summary reports instead of these events being reported separately to the authority. The authority expects this will not impact adversely its awareness of serious incidents associated with the medical devices allowed for marketing and use in the country, and the ability to take the actions necessary to ensure the public health protection and safety of patients. It is important to mention that guidance documents issued by the FDA are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the existing regulatory requirements, as well as recommendations to be followed by medical device manufacturers and other parties involved in order to ensure compliance thereto. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing regulatory framework and has been agreed with the authority in advance. According to the guidance, the application of the VMSR Program is subject to specific conditions. Furthermore, the authority may determine that in certain cases (or for specific product codes) the Program should not be applied. Should it be the case, individual reporting will be required and should be performed in accordance with the general reporting requirements.
Addressing a Public Health Issue
As further explained by the FDA, it may determine that individual reporting is required in case it is reasonably necessary to address a public health issue. In such cases, the general reporting requirements should be followed even if the product codes in question are eligible for reporting under the VMSR Program. According to the guidance, such determination may apply to all reportable malfunctions for a particular device or multiple devices (e.g., all devices within an eligible product code); such determination may also apply to only certain types of malfunctions for the particular device(s), depending on the scope of the public health issue. Should the authority determine that individual reporting is required, it will provide the appropriate notice to the responsible parties. Another notification will be communicated by the authority if it will be determined that the VSMR Program could be applied again. The authority also explains that in case the manufacturer becomes aware of an incident that meets the reporting requirements, and information about such an incident wasn’t included in a summary report, once the notification of individual reporting issued by the FDA is received, the appropriate report should be submitted within 30 days from the date of notification. In order to assist medical device manufacturers in interpreting the approach described herein, the document provides several examples of situations when the authority determines that individual reporting is necessary to ensure public health protection. At the same time, FDA mentions that the examples are not exhaustive, and real-world scenarios could be different. It is also stated that the requirement to submit individual reports could be applied to a particular medical device, multiple devices of the same type, or certain types of malfunctions. According to the guidance, the authority may determine that individual reporting is necessary when:
- FDA has determined that certain reusable devices that fall within eligible product codes may have a high risk of infection if they are not adequately reprocessed, which FDA considers a public health issue;
- There is an ongoing safety signal or other safety-related investigation of a known or potential public health concern;
- Root causes of malfunction events are not well understood.
Manufacturer-Specific Conditions
According to the document, apart from applying conditions to medical devices, the authority may determine that a specific manufacturer is no longer eligible for participation in the VMSR Program. For instance, this could take place due to the manufacturer’s failure to comply with the applicable reporting requirements, to follow the conditions of the Program, or in case additional monitoring is required with respect to specific safety issues. In such situations, the authority will communicate the appropriate notice to the medical device manufacturer in question. Once the said notice is provided to a medical device manufacturer, all adverse events that meet the reporting criteria should be reported individually. Should it appear that there is an incident subject to reporting known to the manufacturer before the notice is received, but still not included in a summary report, the approach described hereabove should be applied.
New Type of Reportable Malfunction
In accordance with the Final VMSR notice, if a manufacturer becomes aware of information reasonably suggesting that a reportable malfunction event has occurred for a device that the manufacturer markets and the reportable malfunction is a new type of malfunction that the manufacturer has not previously reported to FDA for that device, then the manufacturer must submit an individual report for that reportable malfunction in compliance with 21 CFR 803.50 and 803.52. At the same time, the authority also mentions that after submitting the initial report, the manufacturer is allowed to include information about all subsequent similar events in summary reports submitted under the VMSR Program. In summary, the present FDA guidance provides an overview of specific conditions the authority may apply with respect to reporting adverse events under the VMSR Program. The document describes the situations when the Program will not apply, and individual reports are to be submitted.
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