The present document is intended for public consultations. The authority will analyze the feedback and suggestions provided by the industry and take them into account when preparing a final version of the guidance. Once finalized, the guidance will provide additional clarifications regarding 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 current legislation and has been agreed with the authority in advance.
First of all, the authority mentions that under the VMSR Program, in general, if a manufacturer becomes aware of information required in a malfunction summary report that the manufacturer did not submit to FDA because the information was not previously known or was not available when the manufacturer submitted the initial malfunction report, then the manufacturer must submit the supplemental information to FDA in an electronic format in accordance with 21 CFR 803.12(a). As further explained in the document, supplemental information should be submitted within the respective submission timeframes calculated from the date the manufacturer became aware of such information. The parties responsible for medical devices should also comply with other requirements for supplemental reports, namely:
- Indicate that the report being submitted is a supplemental or follow-up report;
- Submit the appropriate identification numbers of the report that is being updated with the supplemental information (i.e., original manufacturer report number on which the report was based); and
- Include only the new, changed, or corrected information.
The authority also explains that in the case the manufacturer becomes aware of important information about adverse events that could result in serious harm caused to patients or users after the summary report is submitted, the information about such adverse events should be reported separately not later than 30 days from the date such information became available to the manufacturer. Apart from this, a supplemental report should be submitted, updating the initial report with additional information regarding the issue in question.
Summary Reporting Instruction
The present draft guidance also provides additional clarifications and recommendations regarding summary reporting which constitutes an important part of the VMSR Program since the eligible issues are not reported individually but included in summary reports. When submitting such reports, medical device manufacturers should follow the “Malfunction Reporting Summary Format” provided in the Final VMSR notice. The said report should be submitted electronically. It is also important to mention that the present draft guidance contains an example of such a form.
As further explained by the FDA, separate summary malfunction reports must be submitted for each unique combination of brand name, device model, and MDR adverse event code(s). Apart from that, medical device manufacturers should also include device identifiers (DI). The authority also mentions that the applicable instructions are the same for both medical devices and device-led combination products.
The guidance also outlines the scope of information to be included in each summary malfunction report submitted under the VMSR Program by filling in the appropriate field of the form to be submitted electronically. According to the guidance, mandatory information includes:
- Description of the event or problem in question,
- Brand name,
- Common device name and product code,
- Manufacturer name, city, and state,
- The model number and other information used to identify a specific device,
- Contact office and manufacturing sites,
- Phone number of contact office,
- Indication of whether the report is related to combination products,
- Indication of the type of reportable event,
- Adverse event problem,
- Additional manufacturer narrative.
Reporting Schedule and Logistics
The scope of the guidance also covers the aspects related to the reporting schedule and logistics. Under the general rule, summary reports related to the products participating in the VMSR Program should be submitted on a quarterly basis. Each report should include the MDR Number comprised of the manufacturer’s registration number, the year of reporting, and a 5-digit sequence number.
According to the guidance, any and all adverse events associated with the eligible product codes should be reported in line with the recommendations provided in the document, unless they are excluded from the scope of the Program, or individual reporting conditions apply.
In summary, the present draft guidance issued by the FDA provides an overview of the reporting requirements applicable under the VMSR Program. The scope of the guidance covers the most important aspects related to the eligibility of product codes and changes thereto, the content of reports, and also the applicable reporting timeframes.
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