Lifeline Biotechnologies (Lifeline) has reported that the regulatory strategy for its First Warning System is well underway and the development of an FDA submission for a 510(k) marketing clearance is expected to be filed later this year.
The company said that once the review is completed, they intend to move forward a fully-compliant 510(k) submission. The submission will be based on the regulatory strategy and would be filed by midyear 2010.
Jim Holmes, CEO of Lifeline, said: “The FDA, in its recent response, opined that the claims concerning the First Warning System’s ability to identify prospective cancerous conditions of the breasts, as set forth in Lifeline’s submission to the FDA in July 2009, would require modification or a premarketing approval process for a Class 3 device. In the development of our regulatory strategy, we have engaged the services of an FDA consulting firm, whose task will be to review the claims made and recommend the appropriate modifications to said claims in order to allow our device to comply with the 510(k) Class 1 or Class 2 medical device guidelines.
“Our FDA consulting firm is also conducting a thorough review and validation of the testing processes Lifeline utilised in the gathering of physiological patient data obtained from over 600 patients in three different clinical trials. In addition, the FDA consulting firm will make a thorough review of our patent pending interpretative computer software system in order to ensure compliance with FDA verification and validation requirements. Our software system technology was developed by Lifeline Biotechnologies, together with our ‘Pattern Recognition’ experts at Nanyang Technological University, Singapore.”