December 17, 2019
The FDA has updated its medical device premarket submission process and now requires submissions to be sent electronically, eliminating hard copies. Issued on December 13th, the change aims to improve the agency’s efficiency.
The Company plans to begin its market approval filing process with a pre-submission meeting with the FDA in early Q2, 2020.
Medtechdive.com reports that the change is expected to “streamline the review process by making an electronic version of a medical device premarket application immediately available for review… FDA said comments it received when the rule was initially proposed were all supportive, with the rule expected to speed the premarket application process, lower costs, reduce errors and free up storage space.”
The change comes one day after the US Senate voted Stephen Hahn, a radiological oncologist, the new permanent FDA Commissioner. Hahn has been described as having a “proactive, not passive approach to device safety”, and as a “clinical trialist, he is interested in reconsidering what endpoints are used in clinical trials and discovering new ways to expedite the product-approval process.”
When asked about modernizing the FDA approval process Hahn said “in the new era where science is moving so quickly, the agency should be more efficient, and we should have more agility.”
Izotropic Corporation CEO Robert Thast commented “The Company is optimistic that a more agile FDA and modernized approval process will result in accelerating the approval process for its Breast CT system, which uses well known imaging technology that has been in use for decades for a variety of other scanning purposes.”
medtechdive.com- FDA Moves to Electronic Premarket Submissions
medtechdive- FDA commissioner nominee backs ‘proactive, not passive’ approach to device safety
marketwatch.com- Five Things You Should Know About Stephen Hahn, The New FDA Commissioner
About Izotropic Corp.
The company is engaged in the development and commercialization of 3-D breast CT imaging technology for early diagnosis of breast cancer, that improves patient comfort, provides true high-resolution images and delivers high diagnostic accuracy. The company has also established Izotropic Imaging Corp, a wholly owned Nevada based subsidiary that will manage operations in the U.S.A.
This document may contain forward-looking statements that are based on the Company’s expectations, estimates and projections regarding its business and the economic environment in which it operates. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to control or predict. Therefore, actual outcomes and results may differ materially from those expressed in these forward-looking statements and readers should not place undue reliance on such statements. Statements speak only as of the date on which they are made and the Company undertakes no obligation to update them publicly to reflect new information or the occurrence of future events or circumstances, unless otherwise required to do so by law.