The new article highlights the key points related to specific products eligible for the program, their periodic evaluation, and eligibility requests.
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The Food and Drug Administration (FDA or the Agency), has published a draft guidance document dedicated to the Voluntary Malfunction Summary Reporting (VMSR) Program. The document is intended to provide additional recommendations to be taken into consideration by medical device manufacturers, as well as clarifications with respect to the regulatory requirements set forth under the existing framework. At the same time, provisions of the guidance are non-binding in their nature, nor are intended to introduce new rules or impose new obligations. Moreover, an alternative approach could be applied, provided such an approach is in line with the current legislation and has been agreed with the authority in advance.
The document describes in detail a special framework introduced by the FDA in order to reduce the regulatory burden faced by medical device manufacturers, and also to ensure better allocation of the authority’s review resources. Under the said framework, the parties responsible for medical devices allowed to be marketed and used in the US may include information about reportable events in summary reports instead of submitting 30-day reports as set forth under the general reporting requirements. However, it is important to mention that only specific product codes are eligible for this program. The present article describes the way the authority intends to review the eligible codes on a periodical basis and also outlines the key points related to eligibility requests the industry representatives may submit.
Periodic Evaluation
According to section VI of the Final VMSR notice, the authority will assess the eligibility of product codes and update them on a periodical basis. For this purpose, the authority will assess the benefit-risk profile of the device in question, as well as postmarket safety information available, while special attention will be paid to the malfunctions of the device. As further explained in the document, the authority generally considers whether quarterly, summary reporting of device malfunctions, in accordance with the conditions of the VMSR Program, would allow FDA to timely identify potential new or increased safety concerns for devices within the product code at issue. Should it be determined that the product code subject to review is eligible, the Product Classification Database will be updated accordingly.
When analyzing information related to postmarket safety of the products suggested for inclusion, the authority will c inter alia, the frequency of reported serious injuries, as well as the number of 5-day reports. Apart from this, the authority will also check whether there were any Class I or Class II recalls related to the medical device in question. The scope of an assessment to be conducted by the authority will also cover the types of malfunctions, their complexity, and also the ability of the authority to identify their root cause. In general, the authority will pay attention to any existing or potential safety issues associated with a medical device in order to determine the reasonable level of detail and frequency of reports to be submitted with respect to malfunctions. For instance, in case it will be identified that the device requires close monitoring due to potential safety concerns, the FDA will determine that the appropriate product code is not eligible for the VMSR Program. The document provides an example of reusable devices that could pose additional risks in case they are not duly reprocessed. For such products, the application of the VMSR Program will not be appropriate, consequently, the respective product codes will not be found eligible. It is also stated that the aspects related to reprocessing medical devices are described in detail in a separate guidance document issued by the FDA.
Summarising the eligibility determinations, the authority states they are intended to follow the overarching principles of the VMSR Program described in [the present draft guidance], to help ensure that summary reporting of malfunctions for all eligible product codes allows FDA to collect sufficient information to understand the reported events, that information can be provided in a common format and is transparent to FDA and to the public, that imminent hazards will be communicated at the earlier time possible, and that summary reporting for devices in any eligible product code streamlines the process of reporting malfunctions.
Eligibility Requests
Another important aspect covered in the present draft guidance document relates to eligibility requests. In accordance with the current legislation, medical device manufacturers are allowed to submit requests with respect to single or multiple product codes to be determined eligible for the VMSR Program. Based on this determination, the interested parties will be allowed to follow the alternative summary reporting pathway when submitting reports related to malfunctions associated with these products. The authority will review the requests received from the industry on a regular basis and update the list of eligible product codes.
The guidance further describes in detail the scope of information to be included in the aforementioned request. According to the guidance, an eligibility request should include:
- The firm’s name, address, registration number;
- The contact person’s name, telephone number, and email address;
- Complete device identification and description, including product code and review panel;
- A complete statement of the request and justification for the request, including a discussion of known information related to the product code’s benefit-risk profile and postmarket safety, and why individual malfunction reporting is not necessary; and
- As part of the justification for the request, a manufacturer should provide a copy of any prior FDA correspondence (including the reference to the Document ID#) regarding device eligibility status and describe any actions taken to address any issues noted in prior FDA correspondence regarding device eligibility for participation in the VMSR Program.
In summary, the present FDA guidance addresses the most important aspects related to the eligibility of product codes for the VMSR Program. The document describes the approach the authority will apply when reviewing product codes and considering eligibility determination and also explains the way industry representatives may apply for the inclusion of new product codes in the list of the ones eligible for the VMSR Program.
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