The US Food and Drug Administration (FDA) on Friday released a proposal that would allow medical device manufacturers to submit malfunction reports for certain devices to the agency in summary format on a quarterly basis.
In 2007, the Food and Drug Administration Amendments Act made changes to FDA's reporting requirements for device malfunctions to allow for summary reporting of malfunction for Class I and Class II devices "that are not permanently implantable, life supporting or life sustaining" on a quarterly basis.
However, since 2011 FDA has required individual malfunction reports for such devices, unless a reporting exemption or variance was granted for specific devices, or until the agency gave further notice on summary reporting criteria.
In 2015, FDA launched a pilot initiative to explore criteria for quarterly summary reporting for low-risk Class I and Class II devices.
Now that the pilot has concluded, FDA says it plans to finalize a voluntary program for quarterly malfunction medical device reporting (MDR) in summary format.
"While manufacturers must report certain device malfunctions to the FDA, these individual reports often describe the same problem, creating a process where the FDA conducts duplicate reviews of common malfunctions," said Center for Devices and Radiological Health Director Jeffrey Shuren.
According to Shuren, the summary reporting proposal will allow the agency more easily identify potential safety issues while reducing the amount of recourses required to review malfunction reports.
During the pilot, FDA says participants were able to reduce the volume of reports by 87%, "while preserving essential information regarding the context around malfunction events."
In a shift from the pilot, FDA says it will establish a list of product codes that would be eligible for summary reporting, including some Class III devices, once its proposal is finalized. The agency also says that it will generally not consider devices in new product codes to be eligible for summary reporting for two years, unless the new product code was issued for administrative purposes only.
FDA says it has developed six principles to support quarterly, summary reporting:
- "The collection of information in summary format should allow FDA to collect sufficient detail to understand reportable malfunction events.
- To increase efficiency, summary malfunction reporting should occur in a common format for the electronic reporting system used.
- Information about reportable malfunctions should be transparent to FDA and to the public, regardless of whether the information is reported as an individual MDR or a summary report. Information contained in a summary malfunction report that is protected from public disclosure under applicable disclosure laws would be redacted prior to public release of the report.
- Manufacturers should communicate information regarding an imminent hazard at the earliest time possible.
- Summary reporting is meant to streamline the process of reporting malfunctions. It does not change regulatory requirements for MDR-related investigations or recordkeeping by manufacturers. (For example, manufacturers participating in the proposed Voluntary Malfunction Summary Reporting Program would remain subject to requirements for establishing and maintaining MDR event files under § 803.18. In addition, under the Quality System (QS) Regulation, manufacturers must evaluate, review, and investigate any complaint that represents an MDR reportable event (see § 820.198 (21 CFR 820.198)).
- Summary reporting information should not be duplicative of information received through other MDR reporting processes."
However, FDA says it will still require individual malfunction reports for malfunctions that are likely to cause or contribute to a death or serious injury within 30 calendar days, and notes that it may require individual reporting in other situations to address public health issues, or bar require specific manufacturers to submit individual reports if they fail to comply with the agency's reporting requirements.
Federal Register Notice