Arch Therapeutics withdraws 510(k) with plans to resubmit after further discussions with FDA.
Arch Therapeutics, Inc., developer of novel liquid, gel, and solid hemostatic and wound care devices, has withdrawn its 510(k) notification for its medical device AC5 Topical Gel, from the Food and Drug Administration (FDA) with plans to submit a new 510(k) as soon as possible following further discussion with the FDA.
Arch voluntarily withdrew the application on December 18, 2017 after receiving questions from the FDA for which an adequately comprehensive response could not be provided within the FDA’s congressionally mandated 90-day review period.
‘A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval.’ — U.S. Food and Drug Adminstration
Arch says it is “committed to collaborating with the FDA” to gain a better understanding of the FDA’s issues, which the company plans to address in a subsequent 510(k) submission.
“We remain confident in the data package that we submitted, and that after working further with the FDA, we will be able to submit another 510(k) that is supportive of clearance for AC5 Topical Gel,” Terrence Norchi, M.D., president and chief executive officer of Arch, said.
While Arch still anticipates obtaining marketing clearance in 2018, commercialization of AC5 Topical Gel is expected to be delayed by approximately one to two quarters until the first half of 2019 based on the information currently available to the company.
The 510(k) submission for AC5 Topical Gel is the first step in a more comprehensive regulatory strategy for this product and the AC5 platform, including internal surgical applications. Plans for additional submissions continue in line with expanding commercial potential.
“Arch remains focused on manufacturing scale-up, clinical regulatory strategy, and developing commercial partnerships, and execution of operating plans,” Norchi said. “We are still awaiting further interactions with the FDA, and expect to provide additional updates as we learn more.”
Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant), and manage wounds during surgery, trauma, and interventional care. The company’s development stage product candidates include the AC5 Topical Gel and the AC5 Surgical Hemostatic Device.
(Source: Arch Therapeutics Inc.)
Filed Under: Drug Discovery
