The US FDA's proposed rule on laboratory-developed tests: Impacts on clinical laboratory testing.

ABSTRACT:

Objectives

To solicit quantifiable feedback from clinical laboratorians on the U.S. Food and Drug Administration (FDA) proposed rule to regulate laboratory-developed tests (LDTs) as medical devices.

Design and methods

A ten-item questionnaire was developed and submitted to clinical laboratory customers of ARUP Laboratories, a national nonprofit clinical laboratory of the University of Utah Department of Pathology.

Results

Of 503 clinical laboratory respondents, only 41 (8 %) support the FDA's proposed rule. 67 % of respondents work in laboratories that perform LDTs and were therefore asked additional questions regarding the proposed rule. 84 % of these respondents believe that the proposed rule will negatively impact their laboratories, while only 3 % believe that the

SUBMITTER: Smith L 

PROVIDER: S-EPMC11193028 | biostudies-literature | 2024 May

REPOSITORIES: biostudies-literature