As discussed in our prior posts (here, here, and here), the Center for Devices and Radiological Health (“CDRH”) has taken much needed steps to improve the most commonly used appeal process, request for supervisory review, available under 21 C.F.R. § 10.75.
The first major activity was the issuance of a draft guidance in December 2011. The draft guidance explained the supervisory review process in greater detail than ever before, established voluntarily target timelines that would substantially shorten a process known for its unbearably lengthy timeframe, and introduced what we referred to at the time as new “wrinkles.” These included, for example, “telescoping” the review process and allowing the submitter to request review by an advisory panel or other experts.
While the draft guidance was pending, Congress passed the Food and Drug Administration Safety and Innovation Act (“FDASIA”), which included provisions related to the medical device appeals process. Specifically, FDASIA section 603 (codified at section 517A of the Federal Food, Drug, and Cosmetic Act (“FDC Act”)) imposed timeframes for appeal decisions that were shorter than those proposed in the draft guidance, and required CDRH to provide a “substantive summary” of the rationale for any “significant decision” being appealed.
On May 17, CDRH finalized its guidance on the appeals process and issued a separate draft guidance with a short Q&A on FDA’s interpretation of the “significant decision” provision in section 517A (referred to herein as “Appeals Guidance” and “Draft Guidance,” respectively). Once finalized, the draft guidance will be included as an appendix to the appeals guidance.
The draft guidance on section 517A states proposes that “significant decision” will include the following:
- not substantially equivalent (“NSE”) or substantially equivalent (“SE”) decisions on 510(k) submissions;
- not approvable, approvable with conditions, or approval decisions for premarket approval applications (“PMAs”) or humanitarian device exemptions (“HDEs”);
- disapproval or approval of an investigational device exemption (“IDE”); and
- failure to reach an agreement on a protocol under section 520(g)(7) of the FDC Act, which allows for discussion with FDA of a protocol for the study of a Class III device or an implantable device.
FDA does not believe that actions earlier in the review process, such as refusals to accept/file, requests for additional information, and deficiency letters, are “significant decisions” subject to section 517A.
As to the “substantive summary,” the draft guidance explains that it “may be the final version of the review memorandum by the lead reviewer or another summary document that includes the following elements: an explanation of the rationale for the regulatory decision; documentation of significant controversies or differences of opinion, i.e., ones the resolution of which had a direct bearing on the regulatory decision; and, references to published literature and consensus standards upon which the decision-maker relied.” Draft Guidance, at 4.
It is not clear whether the entity requesting the summary can specify whether it would like the final version of the review memorandum or the separate document with the specified elements, or whether that decision is left to the review team. If the latter, it is likely that the summary will more likely be the final version of the review memorandum, so the reviewers will not need to prepare a separate document.
There had been some question about whether the summary would be redacted. The draft guidance states that because the memorandum will be provided only to the owner of the proprietary information therein, there should not be any need to redact trade secret and/or confidential commercial information “or any other information in the summary.” Draft Guidance, at 4. However, the memorandum will also be available to anyone who asks under the Freedom of Information Act (FOIA). The version produced under FOIA will be redacted as to trade secret and/or confidential commercial information.
Unfortunately, the draft guidance fails to answer perhaps the most critical question: when will the substantive summary be provided to the requester? Presumably, the entity appealing a decision would like access to the substantive summary prior to preparing the appeal. Under section 517A, the appeal must be filed within 30 days of the significant decision. If the substantive summary is provided beyond the 30 day timeframe, or even late in the timeframe, it will be of little to no use in preparation of the appeal, contrary to the apparent statutory intent.
Certainly, if the review team provides the final review memorandum as the substantive summary, there is no reason why it could not be provided as soon as it is requested. If an alternative document is prepared, it may take longer. There is no excuse, however, for FDA to countenance a system that allows reviewers to withhold the substantive summary for any length of time, given that the applicant has only 30 days to prepare an appeal. The final guidance should address the timing of the substantive summary.
As for the final appeals guidance, apart from inclusion of information related to section 517A, it does not appear to be significantly changed from the draft guidance issued in December 2011. Unfortunately, the final guidance followed the draft guidance in failing to retain the tables found in the 1998 guidance that contained the essentials and helpful “pros” and “cons” of each procedure.
The final guidance states that, while a meeting or teleconference must be granted for a significant decision if requested by the submitter, it is up to the review authority to determine whether one is necessary for a non-significant decision. In fact, “FDA believes that most appeals of actions other than significant decisions can be decided without an in-person meeting or teleconference.” Appeals Guidance, at 6.
The guidance also interprets section 517A to require a request for supervisory review within 30 days, and states that there “is no provision in the statute for extensions or waivers, or for partial submissions or ‘placeholders.’” Appeals Guidance, at 6. If an appeal of a significant decision is submitted later than 30 days after the date of the decision, it will not be eligible for review under section 10.75. Thus, the FDASIA imposed timelines are a two edged sword. On the one hand, they help ensure a speedier supervisory review. But if the appeal of a significant decision is not filed within 30 days, the right to supervisory review is lost. The guidance allows more than 30 days for non significant decisions, but suggests that, as an administrative matter, an appeal past 60 days would be considered untimely. This latter position is legally questionable, since the issue is not addressed in FDASIA and the proposed time limitation has no support in the language of section 10.75.
The guidance reflects section 517A in providing that a decision respecting a significant decision must be made within 30 days of an appeal meeting or teleconference, or, if none is held, within 45 days of the request for supervisory review.
While the proposals in the guidance and the shortened timeframes may help resolve certain frustrations, the real test will be whether supervisors at FDA continue to routinely uphold the decisions of their subordinates, or are interested in considering the issues and making difficult decisions when needed.