ACMG Education Workgroups-May 21 -Update on the Regulation of LDTs: FDA, VALID Act, CLIA Modernization

May 21 -Update on the Regulation of LDTs: FDA, VALID Act, CLIA Modernization

Pdf Summary

The document provides insights into participants' responses regarding the impact of FDA regulations on laboratory-developed tests (LDTs). Among the total 34 respondents, varied perspectives emerged on the course's practical implications. Some participants focus on maintaining testing for pediatric patients, seeking FDA clarification, and planning for compliance. Others express uncertainty, awaiting further guidance, and considering financial and staffing implications. Strategies mentioned include advocating for regulatory changes, new test development plans, and adjusting standard operating procedures. Overall, participants are exploring ways to adapt to evolving regulations, with active engagement in advocacy and compliance efforts among some. The feedback indicates a mix of proactive responses and cautious approaches to navigate the shifting regulatory landscape surrounding LDTs.

Keywords

FDA regulations

laboratory-developed tests

LDTs

pediatric patients

compliance

financial implications

staffing implications

regulatory changes

test development

advocacy