In March 2023, the FDA released a final guidance titled “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency“, which at high level set out a timeline for a variety of products enabled by FDA enforcement policies to begin in summer / fall 2023 to transition to products that may required marketing submission (and eventual clearance or de novo classification). This variety of products noted in this Transition Plan were allowed to operate under fifteen separate FDA enforcement policy guidances released beginning in spring 2020. Enforcement policy, as described in these guidances, in a nutshell allowed for products to be marketed without meeting traditional FDA regulatory requirements, such as FDA registration, meeting of CFR 820 quality requirements and where applicable, pre-marketing submissions to gain 510(k) clearance or de novo classification, as long as certain requirements per these enforcement policy guidances were met by companies marketing product. These enforcement policies are different in practice than Emergency Use Authorization (EUA) mechanisms, that have been used by a number of companies to bring products to the market during COVID-19 Public Health Emergency, so this examination will look specifically at an enforcement policy scenario. This transition plan discussion will not go into all the variations that companies can take using this transition plan, which can ranging from discontinuing the availability of devices once enforcement policies expire, to the continuation of marketing product by seeking traditional marketing submission clearances or approvals, but a useful webinar presentation by FDA addressed this topic.
One such enforcement policy released by FDA in April 2020 is titled “Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” This enforcement policy set out a range of situations that digital therapies, often computer and/or app delivered on a mobile device, could deliver such products for treating psychiatric disorders, without the typical FDA regulatory requirements. This is not a forum to discuss the merits of this or any of these enforcement policies, or to discuss the merits of the FDA winding down any or all of these enforcement policies. This instead is intended to look at the example of a device manufacturer that is currently using one of these 2020 enforcement policies related to the COVID-19 Public Health Emergency to market product, and more importantly, how they plan to transition to traditional FDA regulatory requirements per the guidance the FDA has set forth in their March 2023 Guidance. I often am asked by clients in my consulting work variations of the question “How is someone able to operate on the market like that?” or “How are they meeting FDA requirements?” This examination gives an opportunity in a specific example to see how these enforcement policy rules work and the proposed transition should work.
I selected Akili for this examination for a number of reasons: (1) they are currently marketing FDA regulated product that was de novo classified in the EndeavorRx product (2) they have a product currently marketed using an enforcement policy related to the COVID-19 Public Health Emergency in the EndeavorOTC product, (3) they are a publicly traded company and release public information regarding their regulated products, and (4) they have indicated in public statements future intended actions that are consistent with the FDA Transition Plan guidance. This is not in any way passing judgement on the merits of Akili as a company, merits of any of their products, or in any ways advertising for their products, but gets to the central questions of “How is someone able to operate on the market like that?” or “How are they meeting FDA requirements?”
I was first made aware at a 2015 conference of Akili regarding their efforts to bring a video game like software to the market, with a goal to adjunctively treat Attention Deficit Hyperactivity Disorder (ADHD) symptoms in pediatric patients. In June 2020, Akili received a de novo classification for the EndeavorRx device described as “Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder.” From a regulatory standpoint, getting a de novo classification successfully through FDA is no small feat, but one that comes into play when your technology is so novel there is nothing that could be used for a 510(k) clearance process. This June 2020 de novo classification for EndeavorRx was indicated for children aged 8-12 years old and is a prescription based product. Akili has not received any additional de novo classification or 510(k) clearance (which would likely use their June 2020 de novo as the basis of a 510(k) submission), but Akili has stated in quarterly earnings reporting that “EndeavorRx label expansion filing is under review by FDA. If approved, the proposed label would expand the current 8-12 year old age range to include adolescents aged 13-17.”
In June 2023, Akili announced the release of their EndeavorOTC product via the Apple App store, which is available without prescription for ADHD patients ages 18 and older as it states as an over-the-counter (OTC) product. This was built from their Rx product technology and adapted as applicable for the adult audience. Most importantly, Akili clearly indicated that EndeavorOTC was available due to the enforcement policy on digital health devices for psychiatric disorders noted earlier in stating “EndeavorOTC is available under the U.S. Food and Drug Administration’s current Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. EndeavorOTC has not been cleared or authorized by the U.S. Food and Drug Administration for its indications. It is recommended that patients speak to their health care provider before starting EndeavorOTC treatment. No serious adverse events have been reported in any of our clinical studies.” Akili in late September 2023 expanded EndeavorOTC product to Android based devices and reiterated this enforcement policy utilization. From a logistical execution standpoint, it makes a lot of sense to deploy to user an OTC digital health product that runs on a mobile device primarily, as opposed to seeking a prescription from a health care provider to deploy the product.
So how does any of this impact the FDA “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” you may ask? A key takeaway from this transition plan is that the fifteen separate FDA enforcement policy guidances noted earlier are scheduled to sunset on November 7, 2023 (indicated as Phase 3 of the transition plan), unless the FDA issues a revised final guidance before that date, which seems improbable. So why would Akili elect to publicly announce in June 2023 they are pursuing a product using a guidance that will expire in 5 months? As part of the transition plan guidance, it was noted that “…At this time, FDA does not intend to object to continued distribution of devices within the scope of this guidance where a required marketing submission has been submitted and accepted by FDA before the start of Phase 3 and FDA has not taken a final action on the marketing submission…” Akili has publicly stated that “Akili plans to pursue regulatory approval for over-the-counter labeling of its treatment products. The company is on track to submit its adult clinical trial data later this year to the FDA for OTC authorization of EndeavorOTC.” This last piece is important, as it signals intent that Akili will have a regulatory submission made to FDA and accepted by FDA, which doesn’t mean it is 510(k) cleared or de novo classified by November 7, it simply means the FDA has accepted the marketing submission as being technically complete for their review process. Actual 510(k) clearance or de novo classification could occur some time later in 2023, or early 2024 for that matter. An important nuance, as opposed to traditional 510(k) or de novo marketing submissions outside of enforcement policy orbit, a marketing submission that is transitioning from an enforcement policy must include in the submission a specific transition plan for that device per the transition guidance.
In summary, by information made available by public disclosures, Akili has not only officially activated the use of an enforcement policy that was part of the COVID-19 emergency and signaled clearly that it is available because of this enforcement policy, they have signaled their steps to transitioning this product to traditional marketing submission requirements per the FDA guidance on the transition plan, which would include a marketing submission in the not too distant future. I have no insight into the eventual outcome of their pending (or already submitted) marketing submission for EndeavorOTC, but in all honesty I wish them the best of success in their efforts. Akili has also signaled intent to pursue a conversion of the EndeavorRx product for pediatric patients to an OTC variety in 2024 via a marketing submission, which would undoubtedly occur following a successful OTC marketing submission for adults.
There are undoubtedly many other device manufacturers that are in this same set of circumstances and considering their next steps, since there are 15 enforcement policies for a whole host of products, and those other device manufacturers should be paying close attention and taking actions where necessary to be in compliance with the FDA transition plan, which has required steps even if a company plans to wind down distribution of product, but certainly has a greater degree of effort if product is intended to stay on market as a marketing submission is required.
