Reveles Clinical Service, a specialty Contract Research Organization (Southlake, TX), has been retained by the Company to provide regulatory strategy and clinical trial management, as well as to assist the Company with the necessary documentation as well as clinical plan in preparation for the Pre-Submission Meeting.
Fremont, CA: Health Logic Interactive has announced its continued progress towards an 510(k) pre-submission meeting with the United States Food and Drug Administration (the "FDA") for its diagnostic screening device MATLOC 1 that is expected to occur in September 2021 (the "Pre-Submission Meeting"). An FDA 510(k) pre-submission meeting allows a company, such as Health Logic, to receive input and guidance from the FDA on its proposed FDA 510(k) submission strategy.
Reveles Clinical Service, a specialty Contract Research Organization (Southlake, TX), has been retained by the Company to provide regulatory strategy and clinical trial management, as well as to assist the Company with the necessary documentation as well as clinical plan in preparation for the Pre-Submission Meeting.
"We are excited to be making this progress towards an FDA 510(k) pre-submission meeting and believe this will be an important step in our progression toward FDA 510(K) approval. We expect that the results of the Pre-Submission Meeting should help de-risk the pathway and provide the clarity necessary for a successful 510(k) application," stated David Barthel, CEO of Health Logic Interactive.
