RAP
ResApp Files Pre-Submission Package with the
US FDA
Perth, Western Australia, 31 December 2015 -- ResApp Health Limited (ASX:
RAP), the developer of smartphone medical applications for the diagnosis and
management of respiratory disease, today announced that it has filed a Pre-
Submission package with the United States Food and Drug Administration (FDA)
for ResApp’s diagnostic mobile software application (app).
ResApp has requested a meeting with the FDA to work cooperatively on the
regulatory and clinical plan to support FDA approval of ResApp’s smartphone
app. The meeting is expected to take place in the first quarter of 2016. The FDA’s
Pre-Submission Program is designed to provide applicants the opportunity to
obtain targeted feedback from the FDA in response to questions related to their
marketing application, clinical study protocols or data requirements prior to a
premarket submission.
ResApp plans to pursue US commercialisation as a Class II device supported with
clinical data. The specific requirements for a future FDA submission will be
discussed at the Pre-Submission meeting with the FDA. ResApp is on track to file
a premarket submission with the FDA in mid 2016.
The Pre-Submission package was prepared with the assistance of Experien
Group, LLC, a firm of highly experienced Silicon Valley-based FDA consultants
who have an excellent track record of FDA regulatory submission approvals and
clearances.
Michael Billig, CEO of Experien Group said, “Experien Group and ResApp have
submitted a comprehensive Pre-Submission package to the FDA that includes a
detailed description of their smartphone medical app, an in-depth risk-benefit
analysis, a summary of the clinical results to date and a proposed clinical study
plan. The feedback obtained from the FDA will provide ResApp and Experien
Group with an insight into the FDA’s requirements for the data required to
support a FDA submission.”
Dr Tony Keating, CEO and Managing Director of ResApp said, “Filing this Pre-
Submission package marks a major step towards FDA approval. The resulting
meeting with the FDA will solidify our clinical and regulatory plan, clarifying US
requirements for approval as we move as quickly as possible to make our
technology available in the US telehealth market.”
