Resources & Publications

DTWG RESOURCES

Legislative Drafts and Related Materials

(2021)

DTWG is providing access to certain public materials from other stakeholders as a convenience.  The inclusion of this material does not necessarily reflect the positions or views of DTWG or its members.

  • VALID 2022 Full Text (HERE)
  • VALID 2022 Section-by-Section (HERE)
  • VALID 2021 Full Text (HERE)
  • VALID 2021 Section-by-Section (HERE)
  • E&C Health Leaders Urge Secretary Becerra to Restore FDA’s Authority Over COVID-19 LDTS (HERE)
  • Verifying Accurate Leading-edge IVCT Development Act of 2020 (VALID) (HERE)
  • March 5, 2020 – Richard Burr Press Release: Burr, Bennet Introduce Legislation to Bring Diagnostic Testing into the 21st Century (HERE)
  • March 5, 2020 – Diana Degette Press Release: Lawmakers Introduce Legislation to Expand Nation’s Diagnostic Testing Capabilities (HERE)
  • March 5, 2020 –  Larry Bucshon Press Release: Lawmakers Introduce Legislation to Expand Nation’s Diagnostic Testing Capabilities (HERE)
  • March 5, 2020 – Michael Bennet Press Release: Bennet, DeGette introduce legislation to bring diagnostic testing into the 21st century (HERE)
  • HHS Technical Assistance on VALID Act of 2018 (HERE)
  • December 6, 2018 – Verifying Accurate Leading-edge IVCT Development Act of 2018 (HERE)
  • August 3, 2018 – FDA’s views on the Diagnostic Accuracy and Innovation Act (DAIA) (HERE)
  • March 21, 2017 – Diagnostic Accuracy and Innovation Act (DAIA) Discussion Draft (HERE)
  • November 17, 2015 – Diagnostic Accuracy and Innovation Act (DAIA) Discussion Draft (HERE)
  • November 17, 2015 – Jeff Shuren testimony before the Subcommittee on Health, Committee on Energy and Commerce, U.S. House of Representatives (HERE)
  • November 17, 2015 – Patrick Conway testimony before the Subcommittee on Health, Committee on Energy and Commerce, U.S. House of Representatives (HERE)

FDA/HHS Documents

(2021)

DTWG is providing access to certain public materials from other stakeholders as a convenience.  The inclusion of this material does not necessarily reflect the positions or views of DTWG or its members.

 

  • August 19, 2020 – Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests (HERE)
  • May 22, 2020 – HHS Memo to FDA on Authority to Regulate LDTs (HERE)
  • January 13, 2017 – Discussion Paper on Laboratory Developed Tests (LDTs) (HERE)
  • November 18, 2016 – FDA Delays Finalization of Lab-Developed Test Draft Guidance, Regulatory Focus (HERE)
  • November 17, 2015 – Jeff Shuren Testimony before the Committee on Energy and Commerce Subcommittee on Health (HERE)
  • FDA Draft Guidance (October 2014): Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (HERE)
  • FDA Draft Guidance (October 2014): Notification and Medical Device Reporting for Laboratory Developed Tests (HERE)

Medical Journals and Other Articles 

(2021)

DTWG is providing access to certain public materials from other stakeholders as a convenience.  The inclusion of this material does not necessarily reflect the positions or views of DTWG or its members.

  • The FDA’s Experience with Covid-19 Antibody Tests. New England Journal of Medicine. February 18, 2021. Jeffrey Shuren, M.D., J.D., and Timothy Stenzel, M.D., Ph.D. (HERE)
  • A High-Level Overview of the Regulations Surrounding a Clinical Laboratory and Upcoming Regulatory Challenges for Laboratory Developed Tests.  Laboratory Medicine.  December 7, 2020 (HERE)
  • Covid-19 Molecular Diagnostic Testing — Lessons Learned. New England Journal of Medicine. October 22, 2020. Jeffrey Shuren, M.D., J.D., and Timothy Stenzel, M.D., Ph.D. (HERE)
  • The Validity of VALID Act: Cost Modeling Cancer Diagnostics Regulation By the FDA. American Society of Clinical Oncology Journal.  May 25, 2020 (HERE)
  • Laboratory-Developed Tests: A Legislative and Regulatory Review.  Clinical Chemistry. October 1, 2017 (HERE)

Trade Association Materials

(2021)

DTWG is providing access to certain public materials from other stakeholders as a convenience.  The inclusion of this material does not necessarily reflect the positions or views of DTWG or its members.

  • October 26, 2020 – American Clinical Laboratory Association Comments On VALID Act (HERE)
  • August 20, 2020 – AdvaMed Statement on HHS Rescission of Policies on Laboratory Developed Tests During COVID and Beyond (HERE)
  • March 5, 2020 – American Clinical Laboratory Association Comments On VALID Act of 2020 (HERE)
  • April 2, 2019 – College of American Pathologists Laboratory-Developed Test Oversight FAQs (HERE)
  • February 19, 2019 – College of American Pathologists letter on VALID (HERE)
  • February 15, 2019 – AdvaMedDx VALID Act Comments (HERE)
  • August 20, 2018 – ACLA Comments on DAIA FDA TA (HERE)
  • April 7, 2017 – ACLA Comments on DAIA Discussion Draft (HERE)
  • April 7, 2017 – College of American Pathologists letter on DAIA (HERE)
  • December 13, 2015 – Association for Molecular Pathology Report: Facts FDA Ignored: An analysis of the FDA report, “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies.” (HERE)
  • February 2, 2015 – Comments of the Association for Molecular Pathology to FDA (HERE)

DTWG Public Documents

(2021)
  • DTWG White Paper (HERE)
  • Executive Summary (HERE)
  • October 15, 2020 – DTWG Narrative Response to VALID (HERE)
  • May 22, 2020 – DTWG Narrative Response to VALID (HERE)
  • February 15, 2019 – DTWG Comments on VALID (HERE)
  • August 20, 2018 – DTWG Comments on the DAIA FDA TA (HERE)
  • April 7, 2017 – DTWG Comments on the DAIA Discussion Draft (HERE)

Other Stakeholder Materials

(2021)

DTWG is providing access to certain public materials from other stakeholders as a convenience.  The inclusion of this material does not necessarily reflect the positions or views of DTWG or its members.

  • December 3, 2020 – Congressional Research Service Report: HHS Announcement on FDA Premarket Review of Laboratory-Developed Tests (LDTs) (HERE)
  • March 6, 2020 – Statement from Friends of Cancer Research on the VALID Act (HERE)
  • May 14, 2019 – What Are In Vitro Diagnostic Tests, and How Are They Regulated? Pew Research Center (HERE)
  • May 3, 2019 – Dx Reform Group Coalition Letter to Hill (HERE)
  • August 8, 2018 – Dx Reform Group Coalition Letter to Hill (HERE)
  • May 9, 2018 – Dx Reform Group Coalition Letter to Hill (HERE)
  • Diagnostic Tests. Pew Research Center (HERE)

Historic Documents

(2017)

DTWG is providing access to certain public materials from other stakeholders as a convenience.  The inclusion of this material does not necessarily reflect the positions or views of DTWG or its members.

  • Diagnostic Accuracy and Innovation Act (DAIA) HERE