Open AccessNational Maintenance Cost for Precision Diagnostics Under the Verifying Accurate Leading-Edge In Vitro Clinical Test Development (VALID) Act of 2020
Author(s) -
Richard S.P. Huang,
Laura Lasiter,
Adam Z. Bard,
Bruce Quinn,
Christina Young,
Roberto Salgado,
Jeff Allen,
Jochen K. Lennerz
Publication year - 2021
Publication title -
jco oncology practice
Language(s) - English
Resource type - Journals
eISSN - 2688-1535
pISSN - 2688-1527
DOI - 10.1200/op.20.00862
Subject(s) - legislation , legislature , certification , health care , test (biology) , clarity , computer science , risk analysis (engineering) , actuarial science , business , political science , law , paleontology , biochemistry , chemistry , biology
The proposed legislation Verifying Accurate and Leading-edge In vitro clinical test Development (VALID) clarifies the US Food and Drug Administration's authority to regulate laboratory-developed tests. Many stakeholders have pointed out that the lack of direct US Food and Drug Administration oversight has led to erroneous results that have serious patient consequences-in particular for patients with cancer. Technology Certification is a key provision proposed in VALID to navigate the balance between safety, patient access, and innovation; however, the maintenance cost of the proposed framework after implementation is unclear.