Developing and Implementing Sustainable Real-World Evidence (RWE) Infrastructure for In Vitro Diagnostics (IVDs) Through Systemic Harmonization and Interoperability for Enhancement of Laboratory Data (SHIELD)

  • Overview

    A harmonization and mapping of in vitro diagnostic (IVD) related codes to create infrastructure to support IVDs for future pre-and post-market needs, this project includes pilots planned in antimicrobial susceptibility/resistance, opioid screening and confirmatory testing, testing for acute kidney injury, and diagnosis of sepsis.

  • Impact for NESTcc

    This project could assist in the mapping of relevant codes to improve interoperability of information related to IVDs.

  • Organizations

    The U.S. Food and Drug Administration (FDA)

  • Principal Investigators

    Michael S. Waters, PhD, FDA

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NESTcc's Test-Case study protocol on synthetic mid-urethral slings for stress urinary incontinence in women is open for public comment through June 12. More: 1 day ago

NESTcc is requesting public comments on the study protocol of our Test-Case focused on synthetic mid-urethral slings for stress urinary incontinence in women. The comment period is open until June 12. More: 1 week ago

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