Nothing Appealing in Proposed Device Appeal Regulations: They are Identical to Existing GuidanceJanuary 26, 2018
The title of this blog post should tell you everything you need to know about the proposed appeal regulations announced last week by CDRH (found here). On January 17, CDRH proposed regulations specific to the device appeal process for both 517A decisions as well as non-517A decisions. The notice announcing the proposed regulations states that they are intended to “provide transparency and clarity for internal and external stakeholders” on the device appeal process. However, in our view, the proposed regulations add nothing to the existing guidance available to industry and the Agency regarding the device appeal process.
By way of background, as we have previously posted on (here, here, and here), the device appeal process was significantly modified in the Food and Drug Administration Safety and Innovation Act (FDASIA), which created Section 517A of the Federal Food, Drug, and Cosmetic Act (FDC Act). Section 517A defined certain decisions by CDRH (e.g., 510(k) NSE, PMA denial and not-approvable decisions) that were subject to specific timeframes (i.e., appeal must be received by CDRH within 30 days from the decision and date) and bound CDRH to responding to such appeals:
- within 45 days from receipt if an appeal meeting is not requested; or
- within 30 days from an appeal meeting, if requested, and such meeting must be held within 30 days of receipt of the appeal letter.
The Agency has subsequently issued guidance on this topic: “Center for Devices and Radiological Health Appeals Processes” (Appeal Guidance) and “Questions and Answers About 517A” (Q&A Guidance).
It is worth noting that the 517A process for appeals is generally working. In our experience, the Agency is meeting its statutory timeframes for review of significant decisions. Indeed, if a deadline for a submission fell on a Saturday or Sunday, CDRH was requiring the submission on Friday, which is more restrictive than the deadlines for litigation. Until recently, there has been a lack of published information regarding appeal outcomes, which can be difficult for companies to decide if it is worth taking the risk of appeal while wanting to preserve its relationship with its review division. In a recent U.S. Government Accountability Office (the GAO) report regarding compliance of CDRH’s premarket reviews with the least burdensome standard (available here), it was reported that FDA received 63 517A appeals from 2013 through 2016. Of these 63, 33 related, at least in part, to least burdensome principles. Out of these 33, FDA agreed in whole or in part with the appellant (company) in 11 cases (33%) meaning that FDA’s decision was overturned or modified. These are pretty good odds of getting some relief from an adverse decision where a least burdensome argument is raised, particularly if the company has a good argument.
The 21st Century Cures Act (Cures Act) expanded the list of Agency decisions subject to Section 517A procedures by adding decisions on breakthrough designation requests. In September 2017, CDRH revised its Q&A Guidance to include such decisions on the list of 517A decisions, resulting in the following list of decisions subject to the 517A requirements:
- 510(k): Not Substantially Equivalent; Substantially Equivalent
- PMA/HDE: Not Approvable; Approvable; Approval; Denial
- Breakthrough Devices: Granting; Denial
- IDE: Disapproval; Approval
- Failure to Reach Agreement on a Protocol under Section 520(g)(7) of the FD&C Act
- “Clinical Hold” Determinations under Section 520(g)(8) of the FD&C Act
The guidance includes the following illustrative list of non-517A decisions:
- 510(k) Requests for Additional Information
- PMA Major Deficiency Letter
- 510(k) and PMA Refuse to Accept Letters
- Postmarket Surveillance Orders under Section 522 of the FD&C Act
- CLIA Waiver Decisions
- Warning Letters
- Response Letter to a Request for Information under Section 513(g) of the FD&C Act
The non-517A decisions are not subject to the 517A timeframes, but according to the Appeal Guidance, in order to be timely an appeal of a non-517A decision should be received by FDA within 60 days of the decision date. The Appeal Guidance set no timeframes for CDRH’s review of non-517A appeals meaning that they could potentially languish for extended periods of time – the issue that led to creation of 517A in the first place.
These lists obviously do not cover all FDA decisions. Most notably, de novo submissions are not included. Since FDASIA and the Cures Act (the statutes establishing and revising the device appeal process), de novo submissions have become subject to significant user fees (in excess of $90,000). When CDRH announced its proposed regulations addressing appeals, we hoped FDA would include de novo submissions in the list of 517A decisions, although not required by statute. Certainly given the new price tag, applicants should have the certainty associated with the appeal process for other significant premarket submissions. And, given the increased popularity of de novo applications, more companies are interested in that certainty.
The proposed regulations also do not include any Agency procedures (e.g., timing) for review of non-517A decisions. The notice announcing the proposed regulations does, however, discuss at length the naming of non-517A decisions. Section 517A of the FDC Act pertains to “significant decisions.” In its earlier guidance, FDA used this same terminology referring to 517A decisions as “significant decisions.” FDA stated that it did not want to refer to non-517A decisions as “insignificant decisions” (as may be implied by referring to 517A decisions as “significant”) because they are still important even though not expressly identified in Section 517A. Regardless, however, of what the regulations call these decisions, the lack of Agency procedures for their review highlights their insignificance when it comes to the appeal process and leaves appeals of these decisions at a significant disadvantage as compared to 517A decisions.
Much to our disappointment, the proposed regulations did not address either of these major issues. As indicated at the outset, the proposed regulations simply regurgitate the statutory timeframes and submission types for 517A decisions. With regard to non-517A decisions, the proposed regulations simply state that appeals must be filed by the applicant within 60 days of the decision. There are no requirements for the Agency with regard to reviewing or responding to such appeals. We find the lack of additional clarity and procedures in the proposed guidance somewhat astonishing given that industry and the Agency already understood these procedures and timeframes based on existing guidance. FDA is accepting comments on the proposed regulations through April 17, 2018. We strongly recommend those interested in the appeals process comment. These seemingly arcane procedural elements can help determine the outcome of a submission.