Medical device reporting for manufacturers of Class I and Class II devices that are not implantable/life-sustaining/life supporting (I/LS/LS) may have just gotten easier. FDA announced on August 17 that it is implementing its 2017 proposal to allow device manufacturers to elect to file certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis, rather than as individual MDRs. Summary reporting is available for those events where the manufacturer became aware of information giving rise to the reportable malfunction on or after August 17, 2018. FDA believes that summary reporting will increase efficiency, improve transparency and more readily identify trends.
In its explanation of the Voluntary Manufacturer Summary Reporting Program, FDA continues to engage in legal gymnastics in order to retain maximum flexibility to modify the rules, and takes advantage of a statutory exception Congress granted it in 2007 under the Food and Drug Administrative Amendments Act (FDAAA). The FDAAA amended Section 519 of the Food, Drug and Cosmetic Act (FDCA) to require quarterly summary reporting for Class I and II devices other than:
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Class II devices that are I/LS/LS; or
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Device types that FDA has, by notice in the Federal Register or by letter to the manufacturer or importer, indicated should be subject to individual reporting under 21 CFR part 803 in order to protect public health.
However, FDA never fulfilled the summary reporting mandate, instead deeming that individual MDR reports for all Class I and Class II devices presumptively are necessary to protect the public health. Pursuant to that line of reasoning, it would take an affirmative exercise of agency discretion to grant an exemption, variance or alternative from individual reporting for such devices, per 21 CFR 803.19 (which gives FDA broad flexibility to: (i) vary some or all of the 803 reporting requirements; (ii) vary the timing of reports; or (iii) impose other reporting requirements.)
The new Summary Reporting Program continues to employ this rationale by allowing for summary reporting as a grant of a § 803.19 exemption, rather than as the implementation of the summary reporting directive in Section 519 of the FDCA. By deeming individual reporting for all devices necessary to protect public health, FDA continues to sidestep the Congressional mandate and appropriate for itself the power to swiftly vary its demands on industry through modification of an exemption, rather than through notification and a public health justification for individual MDR reporting. Thus, the exception swallows up the rule, which FDA appears to acknowledge when it provides:
“[T]here are still reportable malfunctions for which submission of individual malfunction reports on a prompter basis than quarterly is necessary to protect the public health - for example, when remedial action is needed to prevent an unreasonable risk of substantial harm to the public health. Those situations may involve class I devices and class II devices that are not [I/LS/LS], and it is not feasible for FDA to provide notice in the Federal Register or by letter to individual manufacturers…each time one of these situations arises.”
Here is some of what you need to know about participation in the Voluntary Malfunction Summary Reporting Program:
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Serious injuries and adverse events still require the filing of individual MDRs.
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New malfunction events for a device that have not been previously reported to FDA must be reported as individual MDRs the first time they occur.
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The program does not affect five-day reporting requirements where a device poses a significant risk to health and create a public health situation that needs to be addressed immediately, and any reportable malfunctions of the same nature that involve substantially similar device must be submitted as individual MDRs until remedial action has been terminated.
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There is no application or notification required for manufacturers who wish to switch to summary reporting; “self-election” is made by submitting a summary report on or before the quarterly deadline. Supplemental reports also must be submitted within the required timeframe.
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Devices that are eligible for quarterly summary reporting will be indicated as eligible in the FDA Product Classification Database by product code.
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Product codes that have been in existence for less than two years will not be eligible for summary reporting (unless the reason for the new code was administrative only).
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Any device subject to an FDA-initiated or voluntary Class I or Class II recall, involving a correction or removal that must be reported to FDA under 21 CFR part 806, will lose its eligibility for summary reporting, and must return to individual event reporting, until the recall is terminated by FDA. If an event was identified for summary reporting prior to the recall and prior to the end of the summary reporting period, the manufacturer must provide a summary report within 30 days of submitting the required report of correction or removal.
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If follow-up information indicates that a serious injury or death occurred, the manufacturer must simultaneously submit both an individual MDR report and a supplement to the summary report (to reduce the number of reported malfunctions) within 30 days of becoming aware of the new information.
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Form 3500A will be used for summary reporting.
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The events reported in a single summary report must involve the same device brand name, model and problem codes.
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Summary reporting is available for device-led combination products only. Summary reporting is not available for postmarketing safety reporting (PMSR) of drug and biologic-led combination products at this time, though FDA will delay enforcement of malfunction reporting requirements for such products under the PMSR rule while it considers a summary reporting approach for such combination products.
The first deadline for summary reporting is October 31, 2018, for information first known to the manufacturer from August 17, 2018 to September 30, 2018.
