Melvin G. Fletcher III
ISO 13485, CMDR, and MDD/CE Marking Certified Lead Auditor
On December 26, 2017, the FDA’s Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research announced a proposed programme for publishing certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis, instead of filing each individual MDR within 30 days. The programme - referred to as the Voluntary Malfunction Summary Reporting Program for Manufacturers - is under a comment period until Feb. 26, 2018.
The goal is to streamline malfunction reporting. As a consequence, the programme will:
- Require Electronic Medical Device Reporting (eMDR)
- Change the timing of malfunction MDRs in certain cases
- Amend MDR number requirements
This programme was outlined in the commitment letter agreed to by the FDA and the medical device industry, and submitted to Congress, as referenced in the Medical Device User Fee Amendments Act of 2017 (MDUFA IV Commitment Letter). In addition, this proposed programme reflects findings from an FDA pilot study on summary reporting formats for malfunction MDRs.
Every year the FDA receives hundreds of thousands of MDRs of suspected device-associated deaths, serious injuries, and malfunctions. The FDA's MDR programme is one of the post-market surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments. Malfunction reports represent a substantial fraction of the MDRs the FDA receives on an annual basis.
Under the programme, manufacturers submitting summary malfunction reports would be required to use eMDR. (To submit these reports, follow the schedule in the table below.)
|Reportable malfunctions that you become aware of during these time frames:||Must be submitted to FDA by:||January 1- March 31, 2018||April 30, 2018|
|April 1- June 30, 2018||July 31, 2018|
|July 1- September 30, 2018||October 31, 2018|
|October 1- December 31, 2018||January 31, 2019|
Moreover, the summary malfunction report requires a MDR number that consists of:
- The registration number of the manufacturer
- The four-digit calendar year in which the event is being reported
- The last five digits, with the first report of each year having the sequence number 00001.
In addition, for combination products that include a device constituent part and that received marketing authorization under a biological product or drug marketing application, the FDA seeks comments on whether a different reporting schedule would be more appropriate.
MDR reportable event needing remedial action
While the proposed programme allows for filing MDRs on a quarterly basis, the reporting requirements of FDA 21 CFR Part 803.53 would continue to apply to manufacturers.
Under FDA 21 CFR Part 803.53(a), for example, a five-day report must be filed if a manufacturer becomes aware of a MDR reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm to public health.
In addition, after a five-day report is submitted, all subsequent reportable malfunctions of the same nature that involve substantially similar devices must be submitted as individual MDRs in compliance with FDA 21 CFR Part 803.50 and 803.52 until 90 days past the date that the remedial action has been resolved to the FDA's satisfaction. Summary reporting of malfunctions may then resume on the regularly scheduled summary reporting cycle.
If the FDA has made a written request for the submission of a five-day report, the manufacturer must submit it, without further requests, for all subsequent reportable malfunctions of the same nature that involve substantially similar devices for the period specified. The FDA may extend the period stated in the original written request if the agency determines it is in the interest of public health (see FDA 21 CFR Part 803.53(b)).
Submission of reportable malfunctions associated with five-day reports would allow the FDA to monitor the time course and resolution of the issue presenting an unreasonable risk of substantial harm to public health.
How to submit a comment
- File electronically at https://www.regulations.gov until midnight Eastern Time by February 26, 2018.
- For written/paper submissions by mail or courier, address to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments received by mail/hand delivery/courier will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before February 26, 2018.
Please note that late, untimely filed comments will not be considered by the FDA. In addition, all submissions received must include the following: Docket No. FDA-2017-N-6730 for “Voluntary Malfunction Summary Reporting Program for Manufacturers.”
Received comments that are filed in a timely manner will be placed in the docket and, except for those submitted as “Confidential Submissions,” will be publicly viewable at https://www.regulations.gov.
If you need assistance or have any questions with compliance issues regarding the Voluntary Malfunction Summary Reporting Program for Manufacturers, contact ICON at www.iconplc.com/devices for more information. Our medical device experts have experience with FDA submissions contained within this new programme.