Posted: 24 Sep 2018 07:59 PM PDT
FDA recently issued its final rule for the Voluntary Malfunction Summary Program, which permits manufacturers to report certain device malfunctions for low-risk products in summary form on a quarterly basis, as an alternative to the Medical Device Reporting (MDR) requirements set forth in section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 360i) and the regulations set forth in 21 C.F.R. Part 803.
Part 803 requires user facilities, device manufacturers, and importers to submit an MDR when it becomes aware of information which reasonably suggests that a marketed device malfunctioned and the malfunction would be likely to cause or contribute to a death or serious injury if it were to reoccur. The summary reporting program will not obviate the need for many of those reports. Rather, this summary reporting program applies only to reporting of malfunction events by manufacturers, and not to deaths or serious injuries, or events requiring reporting by importers or device user facilities. The program also only pertains to certain devices whose product code has been in existence for at least two years. The final rule does not include a full list of devices, instead FDA states that the product code database (available on FDA’s website here) has been updated to indicate whether a particular product type is eligible for summary reporting.
The timing for submitting summary reports is unchanged from the proposed rule, and is set forth below.
Summary Malfunction Reporting Schedule
FDA states that this program is intended to reduce regulatory burdens on companies while still maintaining proper oversight by FDA. It is unclear, however, how much this program will really reduce the burden for companies as FDA states that summary reports should include “a similar level of detail” as individual reports to allow for sufficient understanding of the malfunction, any circumstances that led to the malfunction, and any follow-up steps taken to investigate, correct, and prevent it from happening again. Thus, the only difference appears to be the frequency at which they are reported to the Agency making it appear more like batch reporting rather than “summary” reporting.
FDA received 24 comments from industry, professional societies, trade organizations, and individual consumers regarding the proposed program. Below we summarize some of the key changes to the program based on these comments.
Combination Products
Several comments questioned the program’s applicability to combination products. FDA clarified that device-led combination products are included in the Voluntary Malfunction Summary Reporting Program. Drug and biologic-led combination products are subject to a different reporting system, which will require additional considerations before they are included in this program. As a result, FDA stated that it is delaying enforcement of the malfunction reporting requirements for drug and biologic-led combination products under the final rule. FDA noted that it will consider all relevant comments submitted for the 2017 proposal to grant an alternative reporting mechanism, as well as those submitted on the Post-Marketing Surveillance Program draft guidance in developing the approach for these products.
Limitations of the Program
FDA also clarified the intersection between this new program and existing MDR requirements. For example, the program does not replace the requirement to submit a 5-day report under 21 C.F.R. § 803.53(a), where applicable. In fact, after submitting a 5-day report under 21 C.F.R. § 803.53(a), all subsequent reportable malfunctions of the same nature that involve substantially similar devices must be submitted as individual MDRs under § 803.50 and § 803.52 until the date that the remedial action has been terminated to FDA’s satisfaction. Only then can summary reporting of malfunctions resume on the summary reporting cycle. The same is true when a device is the subject of a recall required to be reported under Part 806: all malfunction events of the same nature involving the same or similar device must be submitted as individual MDRs from the date an 806 report is due to FDA until the recall is terminated by FDA, after which summary reporting can resume on the reporting cycle. The final notice provided additional guidance as to when individual reports must begin and when they may end with regard to a recall. The notice also clarifies that individual MDRs are not required if a recall is Class III, and therefore does not require reporting to FDA.
Similarly, where a company encounters a new type of reportable malfunction, it must submit an individual report to FDA regarding the malfunction. A new type of malfunction is one that has not previously been reported to FDA over the life of the device. After this initial individual report, subsequent malfunctions of this type may be submitted in summary form.
While this program is self-elected by manufacturers of devices with eligible product codes and does not require FDA approval to participate, there are certain restrictions. For example, FDA can provide written notification to manufacturers of certain devices when it determines that individual malfunction reports are necessary to provide additional information and more rapid reporting for an identified public health issue involving certain devices. FDA can also decide an individual manufacturer is not allowed to participate in the voluntary reporting program because of its failing to comply with MDR requirements, failure to follow conditions of the program, or the need to monitor a public health issue. The notice was unclear as to how or when FDA would notify a company that it is no longer eligible to participate, and it does not state whether a company would receive prior notice or an opportunity to respond.
Supplemental Reporting Requirements
The final program notice also clarified how manufacturers should handle supplemental reports for a previously submitted summary event. Consistent with the current requirements, if a manufacturer obtains information required in a malfunction summary report that the manufacturer did not provide because it was not known or was not available when it submitted the initial summary malfunction report, it must submit the supplemental information to FDA in accordance with 21 C.F.R. § 803.12(a). The supplemental report would be submitted as part of the company’s next summary report. It does not need to be submitted separately, unless the new information causes the event to no longer qualify for summary reporting (e.g., new information suggests that a serious injury occurred where previously the event was believed to be a malfunction only with no injury).
Format
As mentioned above, the summary reports will utilize the same electronic submission form used to submit individual MDRs. The summary reports, however, require an additional element in the summary text narrative to identify the number of reportable malfunctions that each report represents. Separate summary malfunction reports must be submitted for each unique combination of brand name, device model, and problem code(s). The final rule provides additional guidance on specific formatting requirements.
New Devices
As stated in the proposed Program, product codes that have been in existence for less than two years will not be eligible for the summary reporting program, unless the new product code was issued solely for administrative reasons. However, FDA will periodically evaluate new product codes after they have been in existence for two years to determine whether they should be added to the list of product codes eligible for the Voluntary Malfunction Summary Reporting Program. The notice also states that manufacturers can also requests that a product code be added to the list of eligible product codes by sending such request to the MDRPolicy@fda.hhs.gov mailbox. Any newly added product codes will be identified in FDA’s Product Classification Database, just like the current group. It appears that it will be industry’s responsibility to continuously check the database to determine whether any new codes have been identified as eligible for the program.
Part 803 requires user facilities, device manufacturers, and importers to submit an MDR when it becomes aware of information which reasonably suggests that a marketed device malfunctioned and the malfunction would be likely to cause or contribute to a death or serious injury if it were to reoccur. The summary reporting program will not obviate the need for many of those reports. Rather, this summary reporting program applies only to reporting of malfunction events by manufacturers, and not to deaths or serious injuries, or events requiring reporting by importers or device user facilities. The program also only pertains to certain devices whose product code has been in existence for at least two years. The final rule does not include a full list of devices, instead FDA states that the product code database (available on FDA’s website here) has been updated to indicate whether a particular product type is eligible for summary reporting.
The timing for submitting summary reports is unchanged from the proposed rule, and is set forth below.
Summary Malfunction Reporting Schedule
| Reportable malfunctions or supplemental information that you become aware of during these timeframes: | Must be submitted to FDA by: |
| January 1–March 31 | April 30 |
| April 1 – June 30 | July 31 |
| July 1 – September 30 | October 31 |
| October 1 – December 31 | January 31 |
FDA received 24 comments from industry, professional societies, trade organizations, and individual consumers regarding the proposed program. Below we summarize some of the key changes to the program based on these comments.
Combination Products
Several comments questioned the program’s applicability to combination products. FDA clarified that device-led combination products are included in the Voluntary Malfunction Summary Reporting Program. Drug and biologic-led combination products are subject to a different reporting system, which will require additional considerations before they are included in this program. As a result, FDA stated that it is delaying enforcement of the malfunction reporting requirements for drug and biologic-led combination products under the final rule. FDA noted that it will consider all relevant comments submitted for the 2017 proposal to grant an alternative reporting mechanism, as well as those submitted on the Post-Marketing Surveillance Program draft guidance in developing the approach for these products.
Limitations of the Program
FDA also clarified the intersection between this new program and existing MDR requirements. For example, the program does not replace the requirement to submit a 5-day report under 21 C.F.R. § 803.53(a), where applicable. In fact, after submitting a 5-day report under 21 C.F.R. § 803.53(a), all subsequent reportable malfunctions of the same nature that involve substantially similar devices must be submitted as individual MDRs under § 803.50 and § 803.52 until the date that the remedial action has been terminated to FDA’s satisfaction. Only then can summary reporting of malfunctions resume on the summary reporting cycle. The same is true when a device is the subject of a recall required to be reported under Part 806: all malfunction events of the same nature involving the same or similar device must be submitted as individual MDRs from the date an 806 report is due to FDA until the recall is terminated by FDA, after which summary reporting can resume on the reporting cycle. The final notice provided additional guidance as to when individual reports must begin and when they may end with regard to a recall. The notice also clarifies that individual MDRs are not required if a recall is Class III, and therefore does not require reporting to FDA.
Similarly, where a company encounters a new type of reportable malfunction, it must submit an individual report to FDA regarding the malfunction. A new type of malfunction is one that has not previously been reported to FDA over the life of the device. After this initial individual report, subsequent malfunctions of this type may be submitted in summary form.
While this program is self-elected by manufacturers of devices with eligible product codes and does not require FDA approval to participate, there are certain restrictions. For example, FDA can provide written notification to manufacturers of certain devices when it determines that individual malfunction reports are necessary to provide additional information and more rapid reporting for an identified public health issue involving certain devices. FDA can also decide an individual manufacturer is not allowed to participate in the voluntary reporting program because of its failing to comply with MDR requirements, failure to follow conditions of the program, or the need to monitor a public health issue. The notice was unclear as to how or when FDA would notify a company that it is no longer eligible to participate, and it does not state whether a company would receive prior notice or an opportunity to respond.
Supplemental Reporting Requirements
The final program notice also clarified how manufacturers should handle supplemental reports for a previously submitted summary event. Consistent with the current requirements, if a manufacturer obtains information required in a malfunction summary report that the manufacturer did not provide because it was not known or was not available when it submitted the initial summary malfunction report, it must submit the supplemental information to FDA in accordance with 21 C.F.R. § 803.12(a). The supplemental report would be submitted as part of the company’s next summary report. It does not need to be submitted separately, unless the new information causes the event to no longer qualify for summary reporting (e.g., new information suggests that a serious injury occurred where previously the event was believed to be a malfunction only with no injury).
Format
As mentioned above, the summary reports will utilize the same electronic submission form used to submit individual MDRs. The summary reports, however, require an additional element in the summary text narrative to identify the number of reportable malfunctions that each report represents. Separate summary malfunction reports must be submitted for each unique combination of brand name, device model, and problem code(s). The final rule provides additional guidance on specific formatting requirements.
New Devices
As stated in the proposed Program, product codes that have been in existence for less than two years will not be eligible for the summary reporting program, unless the new product code was issued solely for administrative reasons. However, FDA will periodically evaluate new product codes after they have been in existence for two years to determine whether they should be added to the list of product codes eligible for the Voluntary Malfunction Summary Reporting Program. The notice also states that manufacturers can also requests that a product code be added to the list of eligible product codes by sending such request to the MDRPolicy@fda.hhs.gov mailbox. Any newly added product codes will be identified in FDA’s Product Classification Database, just like the current group. It appears that it will be industry’s responsibility to continuously check the database to determine whether any new codes have been identified as eligible for the program.
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