In 2007, Congress determined that the public health would be adequately protected if manufacturers and importers of lower risk class I and II medical devices provided summary quarterly reporting of malfunctions to FDA. This system would replace the more burdensome approach of requiring individual 30‑day Medical Device Reports (MDRs) for each device malfunction. At the same time, FDA was granted authority to create exceptions by publishing lists in the Federal Register of class I and II devices that would continue providing individual 30‑day malfunction reports. FDA also was granted authority to create exceptions for specific devices by the simple expedient of sending a letter to the manufacturer or importer.
As amended in 2007, here is what Section 519 of the Federal Food, Drug, and Cosmetic Act statute now says about malfunction reporting:
Records and reports on devices
(a) General rule
Every person who is a manufacturer … of a device intended for human use shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such device is not adulterated or misbranded and to otherwise assure its safety and effectiveness. Regulations prescribed under the preceding sentence—
(1) shall require a device manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices—
* * *
(B) has malfunctioned and that such device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, which report under this subparagraph—
(i) shall be submitted in accordance with part 803 of title 21, Code of Federal Regulations (or successor regulations), unless the Secretary grants an exemption or variance from, or an alternative to, a requirement under such regulations pursuant to section 803.19 of such part, if the device involved is—
(I) a class III device;
(II) a class II device that is permanently implantable, is life supporting, or is life sustaining; or
(III) a type of device which the Secretary 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;
(ii) shall, if the device is not subject to clause (i), be submitted in accordance with criteria established by [FDA] for reports made pursuant to this clause, which criteria shall require the reports to be in summary form and made on a quarterly basis ….
In short, the law today is that devices are subject only to summary quarterly reporting of malfunctions, unless they are in class III, in class II but permanently implantable, life supporting or life sustaining, or excepted from quarterly reporting by FDA in a Federal Register notice or by direct letter.
For unexplained reasons, FDA refuses to implement the statute. We wrote about it in detail five years ago.
Now FDA has announced in the Federal Register a “proposed program for manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form.” 82 Fed. Reg. 60922, 60922 (Dec. 26, 2017). This proposed program “reflects FDA’s findings from a pilot program the Agency conducted to study summary reporting formats for malfunction MDRs.” Id.
FDA acknowledges the 2007 statutory requirement now embodied in Section 519 of the FDCA. 82 Fed. Reg. at 60923. It also acknowledges the benefits of summary reporting for lower risk devices. Id. at 60924. Specifically:
The pilot demonstrated several important findings. First, participants were able to reduce the volume of reports by over 87 percent using the pilot format, while preserving the essential information regarding the context around malfunction events. This increased efficiency in reporting and in the Agency review and processing of malfunction reports. The format also allowed for simple, transparent, and cost-effective reporting through existing electronic reporting processes for submission of electronic MDRs (eMDRs) to FDA, in accordance with the Medical Device Reporting: Electronic Submissions Requirements Final Rule (eMDR Final Rule) published in the Federal Register of February 14, 2014 (79 FR 8832). Based upon observations from the pilot experience, this summary format was usable for both large and small firms with varying numbers of marketed devices. Lastly, summary reports collected in this format could be more easily shared publicly, facilitating transparency of malfunction reporting.
Consistent with these findings, FDA believes that bundling “like events” together into a single summary report description would have benefits for manufacturers, FDA, and the public. For many manufacturers, this approach would greatly reduce the volume of reports that they would need to submit to FDA. For FDA, information would be received in a streamlined manner that would facilitate more efficient understanding of malfunction issues. For the public, summary reports could make malfunction event trends for a particular device more readily transparent. [Id. at 60923‑24.]
Yet, despite this acknowledgment, FDA refuses to follow the law. In the notice, FDA specifically clarifies that this proposed program does not implement the 2007 statute. 82 Fed. Reg. at 60923. FDA casts the proposed program as a voluntary opt-in program pursuant to its regulatory authority to grant MDR exemptions, variances, and/or waivers under 21 C.F.R. § 803.19. Id. at 60924.
The motive for the proposed program is apparently to fulfill certain goals agreed to between FDA and industry in a commitment letter submitted to Congress and referenced in the Medical Device User Fee Amendments Act of 2017. Id. at 60922. It is left unexplained how this commitment letter could override the statute enacted in 2007 and codified in Section 519 of the FDCA.
Indeed, the proposed program actually inverts the statute. As quoted above, Congress directed FDA that all class I and II devices are subject to summary quarterly reporting of malfunctions, unless FDA specifically excepts them in a Federal Register notice or by letter. Under the proposed program, in contrast, FDA will list the eligible product codes and allow manufacturers of products within such codes to opt‑in if certain conditions do not apply. Id. at 60924‑25.
Not to put too fine a point on it, but this “proposed program” represents an agency acting unconstitutionally. The people’s representatives, i.e., Congress, determined a decade ago that the cost and burden of individual reporting of malfunction MDRs was not necessary. The President did not veto the law. Therefore, it is not for FDA to decide whether or not this approach is acceptable. As a constitutional matter, FDA (as part of the Executive Branch) is required to implement that statute. The agency, in other words, is required to faithfully execute the law, not brazenly flout it. See U.S. Const., Art. II, sec. 3.
FDA claims that its own failure to publish a list of excepted devices is what keeps the 2007 amendment to Section 519 from becoming effective. But, even if correct, this failure to act cannot excuse flouting the law for a decade and counting. It seems likely that a trade association or device firm could successfully obtain a writ of mandamus from a court requiring FDA to implement the statute as written. These writs are rarely granted, but this case is egregious enough that a court might issue one. FDA’s own 2015 pilot program and this new proposed program show that the agency is capable of developing an appropriate summary format and, in fact, has done so. The timing (quarterly) is set by statute and needs no agency decision making.
There is nothing more that needs to be done, except for FDA to identify the devices to be excepted. Contra FDA’s position, it is does not appear that this step necessarily prevents implementation of the statute. The law as written does not appear to make publishing a list of exceptions a condition precedent. Rather, it creates a general rule for class I and II devices but grants FDA broad continuing authority to create exceptions (by Federal Register publication and by letter).
Thus, it would be lawful and practically feasible for a court to order FDA to begin accepting summary quarterly reports, subject to exceptions for class I and II devices that FDA may designate by Federal Register publication or by letter. As a matter of discretion, a court could grant FDA a short stay to allow time to develop a list of exceptions before the order becomes effective.
In sum, this proposed program represents continued defiance of the law and a refusal to implement a statute enacted in 2007. FDA should not create the proposed program. Rather, it should immediately implement summary quarterly reporting as required by Section 519 of the FDCA.