U.S. Announced Proposed Program – Voluntary Malfunction Summary Reporting Program for Manufacturers
On December 26, 2017, FDA issued a Federal Register Notice announcing a proposed program permitting medical device manufacturers to submit malfunction medical device reports (MDRs) for certain devices to the Agency in summary format on a quarterly basis (instead of reporting them as individual, 30-day reports). This proposed program reflects FDA’s findings from a pilot program the Agency conducted to study summary reporting formats for malfunction MDRs.
- In 2007, the Food and Drug Administration Amendments Act (FDAAA) made changes to FDA’s reporting requirements for device malfunctions to allow for summary reporting of malfunctions for Class I and Class II devices “that are not permanently implantable, life supporting or life sustaining: on a quarterly basis.
- Since 2011, FDA has required individual malfunction reports for these types of devices, unless a reporting exemption or variance was granted for specific devices, or until the Agency provided further notice on summary reporting criteria.
- In 2015, FDA launched a pilot initiative to explore criterial 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) is summary format.
- FDA states 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. FDA also states that it will generally not consider devices in new product codes to be eligible for summary reporting for two (2) years, unless the new product code was issued for administrative purposes only.
- Summary reporting is meant to streamline the process of reporting malfunctions. It does not change regulatory requirements for MDR-related investigations or recordkeeping requirements by manufacturers.
- FDA states 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. FDA still requires a 5-day report be filed if a manufacturer becomes aware of an MDR reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. Additionally, FDA may require individual reporting in other situations to address public health issues. FDA will also require specific manufacturers to submit individuals reports if they fail to comply with Agency reporting requirements.
- The Federal Register Notice also discusses the specific format for summary malfunction reports, as well as the schedule and other logistics for submitting the summary reports.
- The proposed program does not apply to importers or device user facilities, or affect requirements under part 803 for importers or device user facilities.
- This proposed voluntary program reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments Act of 2017 (MDUFA IV Commitment Letter).
Combination Product Considerations:
- FDA is currently in the process of evaluating device product codes to determine which ones should be eligible. As explained in the MDUFA IV Commitment Letter, this list is to include product codes for Class II implantable devices and Class III devices, as appropriate. FDA is requesting comments on the product codes that should be eligible for this proposed Voluntary Malfunction Summary Reporting Program, including for combination products.
- FDA is considering how this alternative that would permit summary malfunction reporting might apply to combination products that contain a device constituent part and is requesting comments on this issue.
- FDA anticipates that modifications might be needed to the format instructions for the purposes of addressing combination product considerations. Additionally, if combination products that receive marketing authorization under a biological product or drug marketing application are included in the proposed alternative that would permit summary malfunction reporting, FDA anticipates that this reporting would be make through CDER’s or CBER’s electronic reporting system with adjustments made to the format instruction for purposes of reporting through these systems. FDA is asking for comment on these issues.