Remsleep Holdings Inc.'s DeltaWave Mask has received questions from FDA regarding 510k submission (K233415)
TAMPA, Fla., Jan. 22, 2024 (GLOBE NEWSWIRE) -- RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) has received a response to the company’s 510(K) submission K233415. The agency has determined that additional information is required. The agency has asked for additional information regarding Administrative Information, Device Description, Substantial Equivalence (SE), Labeling, Biocompatibility, and Performance testing. All these questions can be answered, and we are in the process of responding with the answers.
The agency has also requested additional Shelf-Life testing for DeltaWave packaging. We are in the process of initiating accelerated Shelf-Life testing for the DeltaWave packaging. This request was a surprise to us, but we will promptly comply.
Remsleep CEO, Tom Wood, commented: “Investors want a 510(K) almost as much as Remsleep. We understand the frustration. Investors can be assured we will answer the questions from the agency, perform the additional tests required, and we will make every effort to gain approval for 510(K) submission (K233415) as soon as possible”.
Judy Strzepek comments: “Remsleep submitted our 510(K) on 10/10/2023. Remsleep received feedback from FDA with a request for additional information. This is not unusual. The type of information requested varies based on the type of product. CPAP device and the mask with accessories needed for sleep apnea therapy is a class II device that requires extensive data and information. So, the agency’s request for clarification of any part of the submission is not unexpected. We are working diligently to address any of FDA’s questions. We will do this as quickly as possible, while ensuring our response is thorough and complete.”
For the years 2022 and 2023, FDA 510(K) clearance for products of this category took the following lengths of time from time submission received by FDA until FDA clearance decision:
Major Competitor | 8 Months |
Major Competitor | 7 Months |
Major Competitor | 1 year |
Major Competitor | 6 Months |
Major Competitor | 9 Months |
Major Competitor | 10 Months |
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This information is from an FDA MDUF commitment letter FDA has published on their website. FDA makes these commitments to Congress for turnaround of submissions. However, it does not state the fact that each time the FDA asks a question, their review clock stops and does not begin again until the company submits a response. So, while 124 calendar days for 2024 sounds good, we don’t know the actual start date (when company submits 510(K)) until FDA gives a decision.
Remsleep has applied for a government grant to perform clinical trials once the 510(K) submission has been approved. The company feels it has a strong chance of being awarded a grant. We will keep investors informed of progress.
Remsleep has been allowed a new US patent for the DeltaWave product(s). The issuance fees have been paid and the new patent is expected to be issued in approximately 7 weeks.
RemSleep will continue to update investors as information becomes available and will be confirmed on the company website, http://www.remsleep.com, and through the company Twitter feed: @RemsleepInc.
About RemSleep Holdings Inc.
RemSleep Holdings Inc. is a medical device manufacturer dedicated to forever changing the level of treatment provided to obstructive Sleep Apnea patients. Our focus is primarily designing and manufacturing devices and products for the treatment of Sleep Apnea and other respiratory conditions. With over 30 years of collective experience in CPAP therapy, the RemSleep team has extensive knowledge and understanding of CPAP and the challenges of patient compliance. We diligently strive for our products to make the difference and improve the condition of those suffering from Sleep Apnea. www.remsleep.com
https://twitter.com/RemsleepInc
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Preya Narain
