After three-plus years, the FDA's device center has published the final version of a guidance for medical device reports (MDR), a document that seems little changed from the draft version. The agency held onto language found in the 2013 draft regarding investigational device exemptions and contract manufacturing arrangements, which critics of the draft had argued would lead to useless duplication of reports of device-related adverse events.

The agency released the draft guidance in July 2013, stating at the time that a manufacturer would have to file a separate report for each and any device that could have been involved in the related adverse event. The FDA also seemed to suggest that it would not specify how many attempts a manufacturer would have to make to retrieve the device before the agency would presume that the manufacturer had made a reasonable effort. (See Medical Device Daily, July 12, 2013.)

The draft and final guidances both stated that the agency intends to publish a rule which would establish malfunction reporting criteria for devices that are subject to quarterly summary reporting. To this end, the agency rolled out a pilot program in 2015 for class I and class II devices that are not permanently implants and are not life supporting or life sustaining, an action that was stipulated by the Food and Drug Administration Amendments Act of 2007.

In the final guidance, the agency sustained a provision in the draft which requires a contract manufacturer and the specification developer to jointly file a request with the FDA that one of the companies be exempt from the MDR requirements for a contract-manufactured device. This provision was criticized by the Advanced Medical Technology Association (AdvaMed) in its Oct. 7, 2013, comments to the docket, which argued that contractual quality agreements that make such provisions "are adequate to ensure that the firm holding responsibility" for MDRs fulfills that obligation.

However, AdvaMed said that the absence of the fulfillment of such a request by the agency would lead to substantial duplication of MDRs, and would lead to redundant attempts to contact the physician[s] and patient in question. AdvaMed said that this would also "result in a drastic increase" in both industry's and the agency's regulatory burden with no concomitant benefit to public health or the agency's ability to fulfill its regulatory and enforcement obligations.

Another portion of the draft that also appears in the final is a passage stating that a manufacturer by definition "becomes aware" that a reportable event has occurred when a trend analysis suggests a need for remedial action by the manufacturer. This language drew opposition from a number of those who commented to the docket, including the Medical Imaging and Technology Alliance of Arlington, Va. MITA said in its Oct. 7, 2013, comments to the docket that the then-current state of regulatory affairs had stipulated that a manufacturer would be liable for reporting any malfunctions that would cause serious harm, assuming there is "any reasonable probability" that this would be the case. MITA added, "if no actual harm has occurred, trend analyses do not provide additional value and should not be required," adding that the association "urges FDA to remove this sentence" before finalizing the guidance.

The final guidance also does not offer any specifics about what constitutes a good-faith effort to contact a device user facility about an adverse event. The agency said it cannot stipulate that administrators at the facility return a device, although the FDA said, "we strongly encourage them to do so." The agency seems to have addressed this in principle via the recent release of a batch of inspectional forms 483 for facilities for failure to file device-related adverse events, although the FDA had declined to issue warning letters for those lapses. (See Medical Device Daily, Oct. 26, 2016.)

One of the changes made for the final guidance was the excision of a section dealing with the two-year sunset of routine reporting requirements for malfunctioning devices. The agency noted in the draft that the 1997 MDR guidance had proposed the two-year limitation on continuous reporting requirements, but the 2013 draft guidance added a requirement that a manufacturer apply to the agency be allowed to cease filing such reports when two years have elapsed since the most recent MDR.

Cook Group Inc., of Bloomington, Ind., made the case that requiring an application for exemption after two years is unnecessary, stating that the two-year limitation "has served FDA and industry well." Cook said that eliminating the need for an application for exemption beyond two years "would ensure the FDA is not burdened" with review of requests pertinent to devices/malfunctions that "are clearly not causing or contributing [to] death or serious injuries with any regularity."

Both the draft and the final versions of the MDR guidance said that MDR requirements do not pertain to otherwise unapproved devices that are under an investigational device exemption, but the agency in both documents said "there is no exception" to MDR requirements for a device that is both approved/cleared and under investigation for an unapproved indication for use. The FDA added that there is also no exemption for unanticipated adverse device effect reporting for devices that are used as controls in a clinical study.

The AdvaMed letter said that requiring MDRs for devices under investigation is duplicative because IDE studies carry a reporting requirement as well. AdvaMed noted that events characterized as "unanticipated adverse device effects" are already under a 10-day reporting deadline for devices used in a study's control arm, and that reporting adverse events for investigational devices "would skew the perceived commercial experience" for that device. The association based that argument on the fact that IDE studies must capture and report all events, including those that "would never be reported as complaints."

The FDA announced it will hold a Nov. 30, 2016, webinar to address any questions raised by the guidance.