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.
About
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.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 11
- **510(k)s submitted (self-reported):** 50
- **Ex-FDA:** Yes
- **Regions served:** US
- **Client types:** sme, startup
- **Location:** United States
- **Availability:** available_now
- **Certifications:** Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485, Advanced Reviewer Certification Program, Reviewer Certification Program, Regulatory Science: Pharmacogenomics
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### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Maria's unique value lies in her transition from an FDA Regulatory Reviewer to a consultant, offering an insider's perspective on the review process. Her decade of direct FDA experience, coupled with a specialization in IVDs and a proven ability to navigate complex pathways like PMAs and EUAs, provides medtech companies with an exceptionally informed and strategic partner.
- **Ideal projects:** The ideal client for Maria is a startup or SME developing innovative In Vitro Diagnostic (IVD) tests, clinical chemistry, or pathology devices. She is perfectly positioned to guide companies through the 510(k), PMA, and De Novo pathways, particularly for their initial submissions or when facing complex regulatory challenges. Her expertise in assay validation, risk assessment, and navigating post-market requirements makes her invaluable for projects requiring robust regulatory strategy and execution. Companies seeking to streamline their regulatory process and ensure compliance from the ground up will benefit most from her specialized knowledge.
- **Last analyzed:** Fri Dec 19 2025 23:55:55 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, clinical-trials
- **Specialties:** ivd, clinical-chemistry, pathology, risk management, regulatory strategy
- **Device panels:** ivd
- **Regulatory pathways:** 510k, pma, ide, post_market
---
- **Type:** independent
- **Years of experience:** 11
- **510(k)s submitted (self-reported):** 50
- **Ex-FDA:** Yes
- **Regions served:** US
- **Client types:** sme, startup
- **Location:** United States
- **Availability:** available_now
- **Certifications:** Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485, Advanced Reviewer Certification Program, Reviewer Certification Program, Regulatory Science: Pharmacogenomics
---
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Maria's unique value lies in her transition from an FDA Regulatory Reviewer to a consultant, offering an insider's perspective on the review process. Her decade of direct FDA experience, coupled with a specialization in IVDs and a proven ability to navigate complex pathways like PMAs and EUAs, provides medtech companies with an exceptionally informed and strategic partner.
- **Ideal projects:** The ideal client for Maria is a startup or SME developing innovative In Vitro Diagnostic (IVD) tests, clinical chemistry, or pathology devices. She is perfectly positioned to guide companies through the 510(k), PMA, and De Novo pathways, particularly for their initial submissions or when facing complex regulatory challenges. Her expertise in assay validation, risk assessment, and navigating post-market requirements makes her invaluable for projects requiring robust regulatory strategy and execution. Companies seeking to streamline their regulatory process and ensure compliance from the ground up will benefit most from her specialized knowledge.
- **Last analyzed:** Fri Dec 19 2025 23:55:55 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, clinical-trials
- **Specialties:** ivd, clinical-chemistry, pathology, risk management, regulatory strategy
- **Device panels:** ivd
- **Regulatory pathways:** 510k, pma, ide, post_market
---
Key Highlights
- 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 h
- Maria's unique value lies in her transition from an FDA Regulatory Reviewer to a consultant, offering an insider's perspective on the review process. Her decade of direct FDA experience, coupled with a specialization in IVDs and a proven ability to navigate complex pathways like PMAs and EUAs, provides medtech companies with an exceptionally informed and strategic partner.
Certifications & Trust Signals
- 11 years experience
- 50 510(k)s submitted (self-reported)
- Ex-FDA
Buyer Snapshot
Best for
- The ideal client for Maria is a startup or SME developing innovative In Vitro Diagnostic (IVD) tests, clinical chemistry, or pathology devices. She is perfectly positioned to guide companies through the 510(k), PMA, and De Novo pathways, particularly for their initial submissions or when facing complex regulatory challenges. Her expertise in assay validation, risk assessment, and navigating post-m
HQ:
United States
Languages:
English
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
