“I was a reviewer at the Center for Devices at FDA. I have dealt with devices and combination products as an FDA employee and as a consultant for more than 20 years. I specialize in products which don’t fit neatly into classification boxes. I can help your firm get an idea of their regulatory path and the testing requirements.
“I can give companies an idea of when the best time is to talk to FDA about the submission requirements for their device. I will provide an initial read on their path and testing requirements as long as the submitted material is less than 60 pages. I can also review the regulatory section of grants.”