Monica Fahrenholtz, PhD serves as a US FDA regulatory submission strategist and project manager, helping medical device companies plan and compile pre-market submissions. She developed expertise in FDA medical device regulation in her service as a lead reviewer for OB/GYN and reproductive health devices at CDRH. In her time at the Agency, Dr. Fahrenholtz reviewed 510(k) and De Novo marketing submissions, IDEs, and Q-submissions including pre-subs and SIRs. She also advised on policy developments for CDRH, including participation in the OPEQ Technical Screening/eSTAR working group that led to a new policy and updates to the eSTAR help text implemented in January 2025. Additionally, she helped develop and modify division-level FDA guidelines for 510(k) review best practices. Prior to joining FDA, she worked in Baylor College’s Office of Surgical Research Administration, authoring and editing scientific manuscripts and grant applications. Dr. Fahrenholtz earned her Bachelor of Science degree in Chemical Engineering from Kansas State and her Ph.D. in Bioengineering from Rice University.
Regulatory Pathways Group Inc.
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