Premise

San Francisco-based digital health start-up Reveri Health reached out to Rook Quality Systems to discuss the regulatory implications of their self-hypnosis mobile app, intended for commercialization in the United States.

With the advent of widely accessible internet and advancement in mobile and health information technologies over the past decade, more and more people are leveraging such technologies for monitoring their own health or for managing their own general well being on a daily basis, and utilizing tools like the Reveri App.

Reveri App is a unique and innovative mobile app that provides self-hypnosis practices to aid users with stress and sleep, pain, eating, quitting smoking, and enhancing focus. Users can practice the self-hypnosis sessions designed by Dr. David Spiegel, the preeminent expert in the clinical uses of hypnosis.

The biggest question an emerging digital health company such as Reveri Health might have would be: "How do we determine whether our device is subject to FDA regulation?"

Scope of Work

Reveri Health requested that RookQS review the Reveri App's Modules, and suggest the appropriate regulatory actions. Based on the initial review and discussion, the RookQS team recommended reviewing the Reveri App's Modules against the criteria of General Wellness designation based on FDA Guidance' General Wellness: Policy for Low-Risk Devices¹.

1. "An intended use that relates to maintaining or encouraging a general state of health or a healthy activity," or
2. "An intended use that relates to the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.".

The RookQS' team informed Reveri Health that the "Letter to File" approach is feasible based on several factors. Reveri Health agreed to this proposal, and contracted RookQS to draft the "Letter to File" to substantiate the general wellness device designation on behalf of Reveri Health.

Engagement

After the kick-off meeting, RookQS determined a concrete timeline for developing the "Letter to File".

1. Week One - Draft Device Description
2. Week Two - Draft Indications for Use (IFU) and Marketing Claims; Review Software Content and Marketing Information.
3. Week Three - Draft justifications for the proposed regulatory pathway
4. Week Four - Review of the Letter to File

Week one Device Description was developed in order to:

• Help the client to understand how we describe their product from the regulatory perspective.
• Allow the client to review and ensure that we capture the product scope precisely.

Once the device description was reviewed and accepted by Reveri Health, RookQSbegan working on the second week assignment to develop the IFU and interpreting the marketing claims in Reveri App. It was necessary to develop the IFU before going to further regulatory assessment. IFU development in this stage was important as:

• It explains if Reveri App's intended use can be defined under General Wellness Devices Guidance

To develop the IFU, our team listened to all the recorded self-hypnosis modules in the Reveri App and reviewed them under the Compliance Policy Guidance Sec. 335.300 Hypnotherapy Devices - Self-Hypnotic Tape Recordings2 and Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation3 by the Food and Drug Administration. At this level, RookQS also reviewed the labeling material on both the website and the app to ensure that no medical claims can be found in the Reveri App or marketing collateral.

In week three, the regulatory pathway was finalized and regulatory assessment was conducted under Section 201 (h) of the Food, Drug, and Cosmetic Act and FDA's General Wellness: Policy for Low-Risk Devices, and this was shared with Reveri.

Upon Reveri's approval on the deliverables- which were shared well in advance of the weekly 30 minutes review call- Rook was able to finalize the "Letter to File" to justify the proposed General Wellness Device Designation ahead of the timeline.

Outcome

Reveri Co-founder Ariel Poler was delighted with the timely wrap-up of the tasks managed and completed by RookQS. "It was a pleasant experience working with the Rook team. Their professionalism and expertise in this domain helped us to enter the market with total peace of mind".

Furthermore, RookQS is working with the technical team at Reveri Health on the best practices for developing Software as Medical Device (SaMD) so that Reveri Health can allocate their resources proactively for their subsequent software product offerings.

References:

1. General Wellness: Policy for Low Risk Devices Guidance for Industry and Food and Drug Administration Staff Preface Public Comment. https://www.regulations.gov. Accessed March 20, 2022.
2. of Regulatory Affairs O. Compliance Policy Guide Sec. 335.300 Hypnotherapy Devices-Self Hypnotic Tape Recordings Guidance for FDA Staff. 2012.
3. 3. Fda. Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration DRAFT GUIDANCE. 2007. http://www.fda.gov/cber/guidelines.htm. Accessed June 10, 2022.