This hub includes curated resources related to lead exposure, blood lead testing, new test regulation and development guides, and other project resources. All links and resources are provided for informational purposes only.

Lead testing fundamentals

Learn about the essentials of lead exposure, and current procedures and challenges in lead testing.
CDC

Learn more about lead, its sources, health effects, and prevention measures.

CDC

Understand the significance of the blood lead reference value, recent changes in guidance, and its role in guiding medical and environmental interventions.

CDC

Learn about the importance and procedures of testing children for lead poisoning, and CDC’s recommendations for screening.

CDC

Overview of the nuances of blood lead testing, its interpretation, and the challenges faced in detection.

Video, CDC

Overview of current lead testing procedures and challenges in mitigating sample contamination during collection.

Regulatory navigation

Navigate the regulatory landscape governing lead testing, including FDA guidelines and classification processes.
FDA

Overview of how the FDA regulates in vitro diagnostic products, including definitions, submission requirements, and approval pathways.

CDC

Background and resources exploring the concept of waived tests, their significance, and the criteria for their categorization by CDC.

FDA

FDA’s De Novo request process, a marketing pathway for novel medical devices without a legally marketed predicate.

Commercial test development

Understand how to take innovative solutions from concept to market.
Stanford University

Frameworks and video modules on health solution development integrating medicine, engineering, and business.

MassVentures

Brief, no-cost courses on commercialization topics, including intellectual property, business model, and go-to-market strategy.

Consortia for Improving Medicine with Innovation and Technology

Platform designed to de-risk and accelerate healthcare innovations, offering guidance, project status visualization, and resource suggestions for healthcare projects.

Submissions for Phase 1 are now closed.