Blackwell, Angela


Summary of Experience:

“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.

Mentoring Services Provided:

“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.”