Regulatory Reviewer
Maria D. S. Basco is a highly accomplished former FDA Regulatory Reviewer with over a decade of invaluable experience at the U.S. Food and Drug Administration (FDA). She brings a profound understanding of medical device regulation and product evaluation, with expertise in assay design, validation, risk assessment, and navigating complex regulatory pathways. Maria has a proven track record of revie...
Experience: 11+ years
Submissions: 50 510(k), 10 De Novo, 15 PMA
Maria D. S. Basco provides regulatory consulting services to clients in:
Possessing a Ph.D. in Microbiology from the University of Southern Mississippi and an M.S. and B.S. in related scientific fields from St. Joseph's College, this individual brings a strong academic foundation in biological sciences. Their advanced degrees demonstrate a deep understanding of scientific principles crucial for evaluating medical devices. This educational background equips them with the analytical rigor and scientific knowledge necessary to excel in complex regulatory review and product development for medtech companies.
Recognized for significant contributions to public health, this professional received the 2020 FDA Commissioner's Special Citation for outstanding leadership in regulating serology tests during the COVID-19 pandemic. They were also part of a team honored with the 2025 Leveraging/Collaboration Award for their work on multi-analyte respiratory antigen tests. This recognition highlights their impact and collaborative spirit within the regulatory field.
With over a decade of experience at the U.S. Food and Drug Administration (FDA), this professional has served as a Regulatory Reviewer, contributing significantly to the evaluation of medical devices. Their tenure includes extensive work within the Center for Devices and Radiological Health (CDRH), focusing on microbiological devices and health technology assessments. They have a proven history of reviewing numerous premarket and post-market applications, including complex submissions like Premarket Approvals (PMAs), 510(k)s, and Emergency Use Authorizations (EUAs). Their experience also extends to developing impactful funding models and analyzing regulatory research relevant to public health threats.
Maria D. S. Basco is a highly accomplished former FDA Regulatory Reviewer with over a decade of invaluable experience at the U.S. Food and Drug Administration (FDA). She brings a profound understanding of medical device regulation and product evaluation, with expertise in assay design, validation, r...
With an impressive 11 years as a former FDA Regulatory Reviewer, Maria D. S. Basco offers unparalleled insight into the FDA's review process, particularly for In Vitro Diagnostic (IVD) devices. Her deep understanding of assay design and validation, risk assessment, and complex regulatory pathways, including PMA supplements, 510(k)s, and EUAs, is a significant asset. Maria's proven track record of reviewing numerous submissions and her recognition for leadership during public health emergencies highlight her critical expertise in ensuring devices meet stringent safety and effectiveness standards. Medtech companies, especially those in the IVD space, need to know that her direct FDA experience translates into strategic guidance for navigating regulatory hurdles and facilitating smoother product development.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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