Business
Remsleep Holdings Inc.'s DeltaWave Mask Moves to Substantive Review of FDA 510k Process
Remsleep Holdings Inc.'s DeltaWave Mask Moves to Substantive Review of FDA 510k Process.
About this update from Remsleep Holdings, Inc.
[{"type":"text","content":"TAMPA, FL / ACCESSWIRE / November 2, 2023 / RemSleep Holdings Inc. (OTCQB:RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) patients, is pleased to announce its DeltaWave mask has moved to the Substantive Review portion of the FDA 510k review process.Previously, the company voluntarily withdrew its 510k submission during the Acceptance Review portion after meeting with the FDA reviewer. The comments from the reviewer at the time led RemSleep to change its 510k consultant and hire the current one who substantially altered the testing and administration protocol to address issues identified by the reviewer. The proposed regimen was further influenced by her extensive experience in regulatory review with respiratory masks. The current FDA reviewer is the same individual who was assigned to the previous submission. The company invites investors to review the submission process timeline by the FDA at the following link: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process#timeline. A summary graphic of the review process is included below: RemSleep CEO, Tom Wood, commented: "Continuing to the Substantive Review portion in the review process is obviously an important step for the company. While there may be additional information requests that arise during this time, we remain confident that the testing regimen established prior to submission was comprehensive and will show the DeltaWave to be safe. Now that the DeltaWave has been submitted, the discussions with interested distributors has heated back up. We recently had a very positive conversation with a past partner who has experience with one of my previous designs and they are looking to accelerate those talks. We remain limited to what we can discuss while the DeltaWave is under FDA review but we continue to focus on being ready to hit the ground running once the review process has concluded. As always, we thank our investors for their patience and confidence in RemSleep."RemSleep will continue to update investors as information becomes available and will be confirmed on the company website: www.remsleep.com; and through the company Twitter feed: @RemsleepInc.About RemSleep Holdings Inc.RemSleep Holdings Inc. is a medical device manufacturer dedicated to...