Showing all posts written by Arash Pia

Arash Pia
Arash Pia focuses his practice on providing patent prosecution and litigation services for his clients.

Arash received his J.D. from Loyola Law School, Los Angeles while he was working full time as a Civil Engineer. At law school, he worked as a mentor for incoming law students. He also worked as a mentor for the award-winning Judge Stephen O’Neil Trial Advocacy Mentoring Program.

Arash received his Bachelor of Science in Civil Engineering from California State Polytechnic University in Pomona. He later received his Master of Science degree also in Civil Engineering from the University of Southern California’s Viterbi School of Engineering in Los Angeles. Before joining the firm, Arash worked on a variety of multi-million-dollar civil design and construction projects, including port facilities, educational buildings, and gas transmission systems. He is a licensed Professional Engineer in the State of California.

FDA Publishes New Monkeypox and Medical Devices Web Page

The FDA has published new web pages about Monkeypox and medical devices. The new web page, titled Monkeypox and Medical Devices, includes information on diagnostic testing, Laboratory Developed Tests (LDTs), and information for test developers. With more than 22,000 confirmed Monkeypox cases in the U.S., the new Monkeypox Medical Devices web comes as FDA takes significant actions to increase Monkeypox testing capacity nationwide following the Secretary of Health and Human Services’ August 9th announcement of public health emergency.

The FDA’s guidance issued for test developers under Policy for Monkeypox Tests to Address the Public Health Emergency describes, among other things, review priorities of Emergency Use Authorization (EUA) requests for monkeypox diagnostic tests. And, on the same day as the FDA guidance was issued, the FDA also issued the first EUA to a commercially available monkeypox test in the United States to Quest Diagnostics for its Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR device. “With this FDA emergency authorization, Quest is positioned to complement the response of public health laboratories and help fight the spread of the virus,” said Jay G. Wohlgemuth, M.D., Senior Vice President, R&D, Medical and Chief Medical Officer, Quest Diagnostic.

Quest Diagnostics is not the only company that has been working on monkeypox diagnostic test kits. Earlier in June, Becton Dickinson announced partnership with CerTest Biotec to collaborate on molecular diagnostic test for monkeypox. Several other healthcare and pharmaceuticals companies have also been linked with this effort. This comes at a time when many of these companies are preparing for a drop in revenue from COVID-19 testing as the threat of COVID-19 reduces.