Updates on Our Discussion With the FDA

Updates on Our Discussion With the FDA

To clarify, the 2022 FDA safety communication is not a recall announcement, and Otteroo nor any other neck float company were recalled.

The FDA has concerns over the use of neck floats on special needs infants, and the safety communication issued was specifically for healthcare providers about using neck floats in aquatic therapy.

Otteroo has provided data and supporting materials to appeal the statement and created this space here to update our progress in response to the June 28, 2022 FDA Safety Communication.

We greatly appreciate those who have reached out to us to offer moral support, advocated for us on social media and shared their personal experiences with the FDA.

Please contact us if you would like to learn how to let your voice be heard!

As always, please make sure you’re within an arm’s length of your baby whenever near a body of water, neck float or not.

Update from 02.21.24

We had a productive meeting with the FDA on 1/23/24 via the Pre-Submission process. Leading into this meeting, we spent months drafting a thorough document to submit to the FDA that outlined Otteroo LUMI’s design, its intended use and the clinical needs LUMI addresses in the special needs community.

The FDA determined that a De Novo Classification Request is the most appropriate regulatory pathway for Otteroo LUMI and offered guidance on what may be needed for a pre-market submission. 

What does this mean for us? 

It means that we now have a realistic end goal with clear steps toward making Otteroo an FDA-approved medical device.

As the next (baby) step, we are designing a Human Factors/Usability Validation test that outlines the user tasks when using Otteroo, and what additional mitigation measures are necessary to address any user errors that arise. Essentially, this type of testing is designed to ensure that users will use Otteroo safely while enjoying the benefits of the product which enables infants to move more freely in a gravity reduced environment.

We want to offer a big shout out to the FDA for having a channel to usher companies with medical devices and foster innovation! We are so grateful for their guidance and support through this process.

And as always, A HUGE thank you to all those who continue to support us so we can keep on floating! 

Update from 09.19.23

First of all, I would like to extend our sincerest gratitude to our community of parents. They rallied and got the attention of the FDA by emailing their positive Otteroo stories to Jeff Shuren, Director of the Center for Devices and Radiological Health at the FDA, after the Safety Communication came out in June 2022.

We have had multiple meetings with the FDA, and in our latest with Dr. William Maisel (Chief Medical Officer and Director, Office of Product Evaluation and Quality of the FDA), he clarified the reasoning behind the FDA's statement about neck strain as a possible risk: “...young infants typically lack strength and neck control to fully hold their heads upright. In addition, low muscle tone and prolonged head lag has been associated with infants with certain disabilities.”

Per the recommendation from Dr. Maisel, we are actively moving forward to discuss the type and extent of evidence necessary to show that Otteroo is safe when used as instructed, and discuss the path forward for Otteroo to be classified as a medical device (in FDA-speak, we will be requesting a pre-submission meeting).

We are working with a research study design team and plan to present our proposed studies to the FDA. The study endpoints will:

  1. Measure the effectiveness of Otteroo at supporting an infant’s head while in the water.
  2. Calculate the force on an infant’s head / neck as a function of their weight (from the neck down) when they are in the water wearing the Otteroo.

We know the weight is miniscule because buoyancy significantly reduces a person’s weight when submerged from the neck down, as reported in a study performed in 1987 which found that with immersion to the C-7 (neck) level, weight bearing was reduced to only 5.9–10% of actual body weight.

In the case of an 11lb infant, their body weighs at most 1lb in water (we measured internally with a volunteer), which translates to 4.5 newtons. During a vacuum-assisted vaginal delivery, an infant’s neck must withstand external forces of up to 115 newtons (during each of the 2-3 pulls), which is significantly higher!

But the FDA is all about data, so we must determine what they deem acceptable to prove Otteroo’s safety.

If you are interested to learn more about Otteroo and its benefits, check out these peer-reviewed studies!

Update from 07.20.22

While it has been a few stressful weeks for us since the FDA released the Safety Communication, we are humbled and beyond grateful for all the support we received from parents and therapists who shared their personal stories with the FDA. Thanks to the advocacy we were able to expedite our conversation with the FDA.

We had a positive meeting with the FDA – we are providing more information to help them properly evaluate the benefits and the risks of neck floats, specifically around the concerns of potential neck strain, which have never been reported to us after millions of Otteroo sessions. We are cautiously optimistic that there is a pathway for Otteroo to be marketed as a safe and effective medical device. We also plan to work with the official channels to set new standards for neck floats, to ensure parents have access to only the safest and highest quality.

We also understand that there are things we can do to communicate better.

For example, the FDA didn’t know of the existing peer-reviewed studies on neck floats. These studies were all IRB (Institutional Review Board) approved. IRBs are formally designated to review and monitor research studies to protect the rights and welfare of human research subjects.

Additionally, they did not know that Cure SMA (spinal muscular atrophy) has included Otteroo in care packages since 2017 (that’s over 500 Otteroos!) thanks to donations by parents whose own babies benefited from accessing aquatic therapy.

Here at Otteroo, we’re celebrating our 10th anniversary in September. However, neck floats were originally invented in China by an obstetrician long before that. Unfortunately, intellectual property is not protected in China, so the market is flooded with cheaply made, unsafe knock-offs that can be easily found online.

We recognize that the road ahead of us is long, but we are optimistic that we will be able to provide the information needed to assure everyone that the proper use of neck floats is not only safe, but can be beneficial in many ways.

Update from 07.01.22

We were heartbroken to receive news of the FDA’s Safety Commission earlier this week advising healthcare providers to stop using neck floats with their special needs patients in aquatic therapy because access to a product that has been proven effective should not be taken away without more explanation and sound research.

While we 100% agree with them about the importance of water safety, we absolutely do not agree with the majority of their content, as well as how the article is written – it is misleading, overly generalized, and demonizes a helpful product category that has been used successfully for years by many families and healthcare providers.

While we cannot speak to the other sellers, in particular the fly by the night overseas sellers, here at Otteroo we have always been laser focused on safety.

We vehemently challenge the claims that “use of neck floats in babies with special needs can lead to increased risk of neck strain and injury.” Based on physics, we believe there is no strain on the neck and are disappointed that such a blanket statement was issued – countless therapists and parents have experiences that show no indication of strain.

We are extremely saddened that a child’s life was taken and another was hospitalized because they were left unmonitored. While these tragic incidents should be taken very seriously, we do believe they could have been avoided and take great care to stress that a parent should always be within an arm's length distance whenever the baby is in any body of water, neck float or not.

We have sent an official request for an emergency FDA supervisory review.

We appreciate those who have come to our defense, and also understand why some would have concerns. We respect your rights to share how you feel.

However, we respectfully ask you to refrain from any judgment, both against our advocates and Otteroo, without a thorough understanding of how Otteroo’s design is intended to leverage buoyancy to bring joy to babies through movement.

If you want to advocate for the right to access a product that has been proven effective and help prevent it from being taken away without more explanation and sound research, please contact us.

We ask for your positive energy as we work with the FDA. We will not give up until we reach a satisfactory outcome for everyone!

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