Maria D. S. Basco
Expert FDA Regulatory Reviewer with 10+ years at FDA, specializing in IVDs, risk assessment, and pathway strategy.
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 reviewing numerous premarket and post-market applications, including PMA supplements, 510(k)s, and EUAs, ensuring devices meet stringent safety, effectiveness, and benefit-risk profiles. Her commitment to public health is underscored by her leadership in regulating vital diagnostic tests during public health emergencies. Maria excels at providing clear guidance to manufacturers, interpreting regulatory frameworks, and facilitating smooth product development pathways for innovative medical technologies.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), PMA
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
11
Num510k Submitted:
50
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
ivd
Technology Types:
ivd_test, combo_product
Accepting New Clients:
No
