Mya has almost 20 years of experience with regulatory and quality, much of it as a consultant. Prior to becoming a consultant, Mya learned the ropes at Chiron and OraSure. Mya has been involved in numerous successful applications before FDA for clients in the US, Canada and EU. She worked with FDA to develop the special controls document and regulation for microarray devices and helped establish the precedent for parallel 510(k) submissions. Mya received a Commissioner's Special Citation at the 2009 FDA Honor Awards in recognition of her work to clear the ABI 7500 Fast Dx. Mya founded Myraqa (formerly Mya Thomae Consulting) in 2002, building on several years as an independent contractor.
Listen to the interview: Diagnostics and the Evolution of the FDA: Mya Thomae, Myraqa
Listen to the interview: Regulation Expert, Mya Thomae, Weighs in on FDA Letter to 23andMe