At Otteroo, our commitment to safety, innovation, and product quality is unwavering. That’s why we’re proud to share that we’re leveraging the FDA’s Pre-Submission (“Pre-Sub”) program to pursue regulatory approval to classify Otteroo neck floats as medical devices through the De Novo pathway.
This effort is a significant step to validate our floats, which are already available and beloved by over 450,000 parents, with evidence-based research.
What is the FDA De Novo Classification Request?
When no predicates (a similar device) exist, a company must go through the De Novo classification process to demonstrate a device’s safety and efficacy.
However, the FDA encourages companies to leverage its Pre-Submission program first!
What is the Pre-Submission Program?
The Pre-Sub program provides companies with the opportunity to receive feedback from the FDA early on in their planning so they can be smart with their resources.
In Otteroo’s case we knew there was no predicate, so the first step was to determine whether our intended use and claims (i.e., what neck float can do for a user) justified a medical device classification.
We are very pleased that after submitting our Pre-Sub and meeting with the FDA on 1/23/2024, FDA noted “a De Novo request seems to be the most appropriate regulatory path.”
In this iterative and ongoing process, companies can submit questions, supplemental information, and get agreement on key parameters of their proposed plan, including clinical study proposals, labels, etc.
This collaborative, invested approach by the FDA is especially beneficial for a small business like Otteroo that needs to be scrappy with resources!
What Otteroo Has Been Doing Since the January Meeting with FDA
We have been busily preparing a few studies, outlined below, to show the safety and efficacy of Otteroo Neck Floats, which we will be discussing with the FDA at our next meeting on 12/5/2024.
Safety - Human Factors/Usability Study
We started with our URRA, or, user-related risk analysis, which involved laying out each task an adult user has to go through when using Otteroo, all the way from unboxing to taking the child user out of the water when an Otteroo session is finished.
We evaluated what could go wrong at each step, and the potential consequences, then developed a risk-mitigation strategy.
Once we had a comprehensive list of user tasks, we designed a usability study, which is a study in which real humans from all walks of life who are not familiar with our product will, in real time, use Otteroo in an observational setting (they will use Otteroo with a baby manikin, however - not a real-life baby).
For the tasks that we cannot readily observe, such as if they read each and every word of our instructions, we ask them to answer questions based on simulated scenarios and label comprehension to demonstrate whether or not we have clearly conveyed the important information and warnings regarding how to use Otteroo.
Effectiveness - Clinical Study
We collaborated with several professors across 3 universities to design a study to show that:
- Otteroo’s design can keep a child user’s head and neck stable.
- Otteroo allows a child user diagnosed with spinal muscular atrophy (“SMA”) to experience greater movement intensity when using it in water than they experience on land, without Otteroo.
We decided to focus on the SMA population first because of our existing relationship with Cure SMA (in 2017 they began including Otteroo in their care packages sent to newly diagnosed children) and the overwhelmingly positive support from pediatric physical and occupational therapists working with that population. These children typically have very little movement, but when in water and supported by Otteroo, anecdotally, they are able to move in remarkable ways - and now we aim to show that with data!
We will also take the opportunity to collect data on buoyancy’s impact on infants in terms of weight reduction so as to show that there is virtually no weight placed on the neck (as all of the studies to date have been on adults) as well as video data of participants’s range of motion in and out of water (to hopefully show that not only is their movement intensity increased while in water, but their range of motion may also be).
We are excited and confident about both study designs, and we are crossing our fingers and toes that the FDA will like them,too!
Next Steps
The regulatory process takes time, but we are determined to invest our resources to have evidence-based research to validate Otteroo’s role in pediatric therapy, and the world!
Stay tuned for updates as we move forward!