RemSleep Holdings Inc.'s DeltaWave Mask has received questions from FDA regarding 510k submission (K233415)

TAMPA, Fla., Jan. 22, 2024 -- 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.”... RemSleep's Press Release - 

Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia

WASHINGTON, Feb. 5, 2024 -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced that on February 4, 2024, it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review. In a letter to Vanda dated July 17, 2023, the FDA had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of the sNDA.

Vanda has extensively studied the efficacy of HETLIOZ® in the treatment of insomnia characterized by difficulties with sleep initiation. A Phase III, multi-center, placebo-controlled, 4-week trial evaluated patients with chronic primary insomnia. Two transient insomnia studies induced by phase advance of the sleep-wake cycle were also conducted with five-hour and eight-hour phase advance, which showed a significant effect the first night in improving sleep parameters... Vanda Pharmaceuticals' Press Release [PDF] -