FDA Extends Malfunction Summary Reporting Program to Combo Products
Posted 16 August 2018 | By
In a Thursday notice finalizing a new industry program for reporting device malfunctions, the US Food and Drug Administration (FDA) announced it has extended the eligibility of manufacturers that can chose to participate to include those with combination products.
The Voluntary Malfunction Summary Reporting Program was first proposed
last December as an alternative to reporting certain device malfunctions via medical device reports (MDRs) with the goal of reducing regulatory burden on eligible manufacturers and agency staff.
“Every year, FDA receives hundreds of thousands of MDRs of suspected device-associated deaths, serious injuries, and malfunctions,” the agency said. “Malfunction reports represent a substantial fraction of the MDRs FDA receives on an annual basis.”
Under the voluntary program, malfunction reports can be submitted to FDA’s Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER) in a summary format and on a quarterly basis. All other MDR requirements will remain unchanged.
The reportable malfunctions must be submitted within the specified time frames, as the table below shows, but the summary reports allow for the grouping of events that are the same or similar.
The agency said it expects for this alternative to “reduce the number of reports manufacturers need to submit to FDA by approximately two thirds.”
As part of the proposal, FDA sought comments from stakeholders on how the summary reporting approach could apply to combination products. Of the 24 comments, some raised concerns with regard to drug and biological-led combination products such as the device code-based approach to eligibility, among other issues.
Still, the agency concluded that manufacturers of device-led combination products can use its eMDR data system to use the reporting alternative as they are already subject to MDR requirements under current regulations.
The final version of the program received other changes in response to the comments, which are described and addressed throughout the notice.
The reporting format was slightly tweaked for further clarifications on certain aspects such as devices manufactured at multiple different sites, including certain patient demographics in summary reports and the addition of “serial number” formatting instructions.
Further, the notice explains the pushback from the agency on numerous issues expressed in the comments. These relate to a potential risk of an adverse event, the exclusion of device importers, and the lack of a formal definition for the terms “similar device” and “similar complaint” for the purposes of using the program, among other issues.
The six principles
that form the foundation for voluntary malfunction summary reporting via the new program are centered on the goals set forth in the commitment letter under the latest reauthorization of the medical device user fee program.
Only manufacturers of devices under eligible product codes, which are identified in FDA’s product classification database, can choose to participate. Those devices under codes that have been in existence for less than two years as well as all class III and class II devices that are permanently implantable, life supporting or life sustaining are currently ineligible.
Yet FDA intends to periodically revisit the list of eligible product codes to determine whether they should be added. Manufacturers can also submit a request for the inclusion of a product code.