Medical device reporting (MDR) is an important post-market activity that helps to ensure patient safety. The FDA receives over two million medical device reports annually, with malfunctions accounting for most reports received. The Voluntary Malfunction Summary Reporting (VMSR) Program was created to streamline the malfunction reporting process.
To help manufacturers better understand and effectively utilize the Voluntary Malfunction Summary Reporting Program, the FDA issued a new draft guidance document, “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers,” on December 9, 2022. The VMSR program, which allows manufacturers to submit malfunction summary reports for specific devices on a quarterly basis, is thoroughly explained in this document by providing program benefits, conditions, and examples of its usage. This draft guidance is not intended to change the VMSR Program.
The FDA Medical Device Reporting Program is a post-market surveillance tool used to look at device performance, detect safety issues, and help to make informed benefit-risk assessments. With malfunction reports representing most of the MDRs received annually, the FDA set out to create the Voluntary Malfunction Summary Reporting (VMSR) program to streamline malfunction reporting and to benefit the FDA, the public, and manufacturers. The VMSR program allows manufacturers of class I and II devices with specific product codes to submit malfunction summary reports for each unique combination of brand name, device model, and problem code quarterly, as opposed to the typical 30-day reports submitted individually. The FDA launched a pilot VMSR program in 2015. After two years, it was determined that the program successfully improved FDA’s use of resources and promoted transparency to the public. In 2018, the VMSR program was officially granted as an alternative to individual reporting under 21 CFR Part 803.19 (Medical Device Reporting). The draft guidance document breaks down the VMSR program into categories, including program eligibility, program conditions, supplemental reports, and how to complete a summary report.
In the draft guidance, the FDA clarifies which manufacturers are eligible for the program; the devices must be class I or II (cannot be a life-sustaining, life-supporting, or permanently implantable class II device) under specific product codes. Product codes in existence for less than two years are generally not eligible. The FDA periodically reviews product codes for eligibility, and manufacturers may submit a request for a review of specific product codes. Eligible product codes can be found on the FDA website in the Product Classification database (link below). Within this database, Summary Malfunction Reporting is designated as “Eligible” or Ineligible” for each product code. Product Classification (fda.gov) The VMSR program is “self-elected” by manufacturers who fit program criteria, and therefore summary reports may be sent to the FDA without any separate application to participate in the program. It is also noted that participation in the program is not required for manufacturers, who can continue to utilize individual reports for malfunctions. Importers and device user facilities are not required to report malfunctions to FDA and, therefore, will not use this program.
The FDA identifies which MDR reportable events do not fall under the scope of the VMSR program and, therefore, cannot be included in the summary report:
- Reportable death and serious injury.
- Reportable malfunction associated with a 5-day report.
In addition, the following instances constitute an individual 5-day or 30-day report instead of being included in the summary report:
- Reportable malfunction is associated with a 5-day report.
- A reportable malfunction is under Class I or Class II device recall.
- The FDA has determined that individual MDR reporting is necessary due to public health issue (such as unknown risks or root causes that are not well understood).
- The FDA has determined that a device manufacturer may not report in summary report format due to failure to comply with applicable regulatory requirements.
- A new type of reportable malfunction occurs for a device.
In cases where new information comes to light after a summary report was previously submitted, manufacturers can utilize an MDR supplemental report to inform the FDA of new, changed, or corrected information regarding their device. It is stated that supplemental reports cannot be used if the new information suggests that an individual report is needed (such as a death or serious injury).
How to use Summary Reporting and Timelines
Summary Malfunction Reports are submitted using an electronic format of Form FDA 3500A. The draft guidance lays out the information needed to complete relevant sections of the form, along with an example of a malfunction summary report in Appendix A. These summary reports will be made available to the public through the MAUDE database. The FDA also reemphasizes the timelines (see Table 1) for quarterly submissions, which is the same for all manufacturers.
|Reportable malfunctions that a manufacturer becomes aware of during these timeframes||Should be submitted to the FDA by|
|January 1 to March 31||April 30|
|April 1 to June 30||July 31|
|July 1 to September 30||October 31|
|October 1 to December 31||January 31|
Table 1 – VSMR Timelines Conclusion
The intent of FDA’s draft guidance document “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers” is to give manufacturers clarity on the requirements of the VMSR program and explain how it can be utilized within their post-market quality management system. It is important to note that this draft guidance is not meant to alter the program; it is only used to clarify VMSR. The FDA explains that the program increases transparency to the public, helps the FDA be more effective in their oversight, and decreases burden on manufacturers. By issuing this draft guidance, the FDA aims for manufacturers to better understand the program and take advantage of its benefits.
Once finalized, manufacturers can use this draft guidance as a framework to implement the VMSR Program into their systems. For anyone interested, comments on this draft guidance can be submitted through February 2, 2023, in the link below. Regulations.gov
Danielle Short – Associate Medical Device Consultant