APPY1 regulatory update

Venaxis said FDA provided the company with questions and requested information as part of the agency’s review of a 510(k) application for APPY1 to identify patients that are at low risk for appendicitis. The company said it is compiling responses and seeking clarification from FDA, but declined to disclose further information on the agency’s request. The company is also seeking concurrent de novo classification of the test by FDA. FDA’s de novo pathway is an alternative path to market for devices that are lower risk and may not require a PMA but are of a new type and would not be cleared via the 510(k) pathway. ...