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IVD and CDx Regulatory Affairs Consulting

Providing global regulatory support for diagnostics across the assay development lifecycle.

Precision for Medicine’s IVD Regulatory Consulting Team has over 100 years of cumulative industry experience in In Vitro Diagnostics (IVDs), instruments (software and hardware), and specimen collection devices. Our experts offer comprehensive regulatory planning and strategy for all types of IVDs and Companion Diagnostics (CDx) across all scientific methodologies and therapeutic areas. We design and execute on regulatory solutions to facilitate global clinical trial assay testing and registrations in the United States, Canada, European Union, United Kingdom, Norway, Iceland, Switzerland, Liechtenstein, Japan, and Australia, among others.

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Diagnostic regulatory support, from bench to bedside

Bringing a product from development to market can be challenging to navigate, which is why it is crucial to have a team of experts who know the ins and outs of the development life cycle for your diagnostic or Companion Diagnostic (CDx). Our team of In Vitro Diagnostic (IVD) Regulatory Affairs experts are ready to walk you step-by-step through these processes and guarantee to streamline the path to success for your IVD product.

200 IVD and CDx Presubmissions, IDEs, ITAs, and Annex XIV Submissions
250 510(k), Special 510(k)s, EUAs, De novos, PMAs, PMA supplements for IVD and CDx submissions in the US

We support the transition of laboratory developed tests (LDTs) to IVDs through the 510(k), de novo, or PMA pathways.

Our experts develop customized regulatory roadmaps, clinical trial enabling submissions, analytical and clinical trial designs, and regulatory submissions for commercialization of kit-based IVDs and CDx.

  • Assay Development and Regulatory Strategy

    • Global Regulatory Strategy and Roadmap Development
    • Product Design Considerations
    • Regulatory Pathway Identification
    • Predicate Device Identification
    • GAP Analysis for CLIA to CLSI
    • Biomarker Definition

  • Assay Validation, Preclinical Submissions, and Evidence Collection

    • Development of Analytical, Clinical, Flex, and User Study Designs
    • Risk Assessment and Study Risk Determination Q-Submissions
    • Pre-IDE Q-Submissions, IDE Applications, and Presubmissions
    • Annex XIV Submissions
    • Early Agency Meetings
    • Bridging Strategies
    • CDx Partner Qualification and Vetting

  • Timely Regulatory Approval 

    • 510(k), Special 510(k), EUA, De Novo, PMA and PMA Supplement Submissions
    • IVDR compliant Technical File Documentation
    • Breakthrough Device Designations
    • Compliance With UK MDR 2022 and UKCA Mark Approvals
    • Global Registration Filings
    • Regulatory Agency and Notified Body communications

  • Commercialization Planning

    • Labeling/Advertising/Promotion
    • BIMO and Notified Body Audit Preparation
    • Registration and Listing

  • Product Launch & In-Market Support

    • Postmarket Surveillance
    • QMS Certification
    • Product Life Cycle Management
    • Product Updates and Supplementary Filings

In addition to US regulatory services, Precision provides regulatory consulting services across Europe

EUUK

  • Regulatory strategy and roadmap

  • Product risk classification and conformity assessment routes

  • Clinical trial assay testing requirements based on assay use

  • Gap assessments from IVDD to IVDR documentation file

  • Clinical trial enabling Annex XIV Submissions to the competent authorities and local ethics committees for clinical trial assays used for medical purpose

  • Technical documentation file development for compliance to IVDR CE marking

  • Labeling (CE mark)

  • Notified Body ID and communications

  • Regulatory strategy and roadmap

  • Conformity assessment routes

  • Clinical trial assay testing requirements based on assay use

  • Notification to the UK Medicines and Healthcare products Regulatory Agency (MHRA) and ethics committee for a CTA

  • Essential requirements

  • Device registration submission to MHRA

  • Labeling (UKCA mark)

  • Notified Body ID and communications

Explore resources related to our IVD and CDx offerings

With people across 70+ countries, Precision provides comprehensive services that streamline and accelerate IVD and CDx development at a global scale

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Read Precision's articles related to IVD and CDx consulting

Read: Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics Companion Diagnostics

Translational Research

Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1714461729999, hs_published_at=1738195925606, description=Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Kennon%20Daniels.webp',altText='Kennon Daniels',fileId=165893120790}, linkedin=https://www.linkedin.com/in/kennon-daniels-ph-d-84a90b6, hs_name=, hs_path=, lastname=Daniels, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778882, hs_child_table_id=0, hs_updated_at=1714461102447, hs_published_at=1738195925606, description=Dr. Curnutte has more than ten years of research and regulatory affairs experience focused on in vitro diagnostics (IVDs). She has held regulatory positions at both device and pharmaceutical companies, during which she led seven U.S. and ex-U.S. companion diagnostic registrations. She has extensive expertise in CDx development and clinical trial integration, IVD product development, next-generation sequencing technologies, and translation of U.S. regulatory strategy to major markets., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Margaret%20Curnutte.webp',altText='Margaret Curnutte',fileId=165892782094}, linkedin=https://www.linkedin.com/in/margaret-curnutte-93558913, hs_name=, hs_path=, lastname=Curnutte, hs_created_at=1709645745113, hs_is_edited=false, hs_deleted_at=0, name=Margaret, job=, slug=margaret-curnutte, email=, hs_updated_by_user_id=51739740}, third={}})
  • Kennon D. avatar

    Kennon D.
  • Margaret C. avatar

    Margaret C.
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Read: Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies

Translational Research - Gene Therapies

Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1714461729999, hs_published_at=1738195925606, description=Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Kennon%20Daniels.webp',altText='Kennon Daniels',fileId=165893120790}, linkedin=https://www.linkedin.com/in/kennon-daniels-ph-d-84a90b6, hs_name=, hs_path=, lastname=Daniels, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778882, hs_child_table_id=0, hs_updated_at=1714461102447, hs_published_at=1738195925606, description=Dr. Curnutte has more than ten years of research and regulatory affairs experience focused on in vitro diagnostics (IVDs). She has held regulatory positions at both device and pharmaceutical companies, during which she led seven U.S. and ex-U.S. companion diagnostic registrations. She has extensive expertise in CDx development and clinical trial integration, IVD product development, next-generation sequencing technologies, and translation of U.S. regulatory strategy to major markets., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Margaret%20Curnutte.webp',altText='Margaret Curnutte',fileId=165892782094}, linkedin=https://www.linkedin.com/in/margaret-curnutte-93558913, hs_name=, hs_path=, lastname=Curnutte, hs_created_at=1709645745113, hs_is_edited=false, hs_deleted_at=0, name=Margaret, job=, slug=margaret-curnutte, email=, hs_updated_by_user_id=51739740}, third={}})
  • Kennon D. avatar

    Kennon D.
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    Margaret C.
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Read: COVID-19 Home Testing: Looking Back at the Journey to Authorization COVID-19 Home Testing: Looking Back at the Journey to Authorization

Clinical Trials - Translational Research

COVID-19 Home Testing: Looking Back at the Journey to Authorization

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778851, hs_child_table_id=0, hs_updated_at=1715692769174, hs_published_at=1738195925606, description=Jo-ann Fabia Gonzales is an experienced regulatory affair professional with more than 20 years of experience in biotechnology. Her career has a rich focus on medical devices and IVD regulatory support., avatar=Image{width=720,height=896,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Joann_Gonzales.png',altText='Joann_Gonzales',fileId=167372995923}, linkedin=https://www.linkedin.com/in/joannfabilagonzales-57527a4, hs_name=, hs_path=, lastname=Fabia Gonzales, hs_created_at=1709645745082, hs_is_edited=false, hs_deleted_at=0, name=Jo-ann, job=, slug=jo-ann-fabia-gonzales, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
  • Jo-ann Fabia Gonzales avatar

    Jo-ann Fabia Gonzales
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