In the draft MDR guidance discussed in our prior post, FDA stated that it has not yet issued a Federal Register notice required by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) regarding certain changes to the MDR malfunction reporting requirements. FDAAA changed the malfunction reporting requirements for all Class I devices, and Class II devices that are not permanently implantable, life supporting, or life sustaining—in other words, a majority of currently marketed medical devices. And by “changed,” we mean that FDAAA significantly reduced the reporting obligations of manufacturers of those types of devices. As amended by FDAAA, section 519(a) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) requires regular malfunction reporting only for Class III devices, Class II devices that are permanently implantable, life supporting, or life sustaining, and “a type of device which [FDA] has, by notice published in the Federal Register or letter to the person who is the manufacturer or importer of the device, indicated should be subject to such part 803 in order to protect the public health.” Manufacturers of all other devices are required to report malfunctions only “in summary form and made on a quarterly basis,” as described in criteria to be issued by FDA. FDC Act § 519(a)(1)(B)(ii).
Rather than issuing a notice indicating the devices that FDA believes should continue to be subject to the current Part 803 malfunction requirements, in March 2011—four years after enactment of FDAAA—FDA issued a notice in the Federal Register stating that it “intends to provide notice in the Federal Register that lists the types of devices that should be subject to part 803 in order to protect the public health, as required by section 519(a)(1)(B)(i)(III) of the FD&C Act.” 76 Fed. Reg. 12743, 12744 (Mar. 8, 2011). In the interim, however, “in the interest of public health, FDA is publishing this notice under section 519(a)(1)(B)(i)(III), to clarify that, to the extent there is any confusion as to current malfunction reporting requirements, all device manufacturers and importers of class I and those class II devices that are not permanently implantable, life supporting, or life sustaining, must continue to report in full compliance with part 803, pending further FDA notice under section 519(a)(1)(B)(i)(III), as to specific devices or device types subject to part 803 . . . . FDA considers it necessary to subject all such devices to part 803 in the interim, in order to protect the public health by ensuring that there is no gap in malfunction reporting for any device.” Id. (emphasis added). In effect, through this sweeping blanket statement of policy, FDA has tried to undo a congressional directive.
This language is repeated in the MDR draft guidance, issued six years after enactment of FDAAA. FDA again insists that it does intend to publish a list of the types of devices that will continue to be subject to the current Part 803 requirements, but in the meantime, everyone should just keep on reporting as if FDAAA had never been enacted. Notably, FDA does not provide a timeframe by which it intends to publish this long-absent Federal Register notice. Given FDA’s track record with some other congressional directives, such as reclassification of Class III devices and the UDI regulation, we know FDA can take quite a while.
This language in the draft guidance is a surprise for a number of reasons. First, it seems that this change effected through FDAAA has stayed fairly under wraps, and FDA’s failure to comply with the statutory mandate to issue a notice has gone rather unobserved. It was not raised as an issue to address in FDASIA last year, and manufacturers don’t seem to be complaining about FDA’s failure to comply with its statutory mandate to reduce the regulatory burden of malfunction reporting for a large number of devices. (Given that the MAUDE database reflects over 500 malfunction reports in any given week, this is potentially a large collective burden.) Second, it is somewhat surprising that FDA bothered to address this issue in the draft guidance. FDA could probably have issued the draft guidance with no mention of its failure to comply with a congressional mandate, and its omission may have gone unnoticed.
Most important, it is clear that Congress did not intend FDA to issue a short Federal Register notice simply stating that it believes, for the protection of public health, manufacturers of all devices must continue to comply with the Part 803 malfunction reporting requirements. If that was Congress’s intent, it did not need to change the statutory language. Congress obviously believed that the malfunction reporting requirements were overly burdensome, without an obvious benefit, for a majority of devices, and it sought to reduce that burden.
Companies making low risk devices that are cited for failure to submit MDRs may want to raise this issue as a defense. As is evidenced by FDA’s failure to comply, and the increased burdens it seeks to impose on manufacturers in the new draft guidance, it does not seem that FDA intends ever to comply with the requirements of section 519(a)(1)(B)(i)(III). Industry should consider whether it is worth raising this issue with Congress in an effort to force FDA’s hand. Those efforts worked for a number of issues addressed in FDASIA (e.g., appeals timeframes, the 510(k) modifications draft guidance, and pushing FDA to issue a UDI regulation). Congress intended for FDA to develop a targeted list of products that should remain subject to the malfunction reporting requirement. Going to Congress may be the only way to solve the mystery of the missing MDR notice.