FDA’s LDT Proposal Raises Questions About Clinical Validity
Debate is underway on whether current CLIA review of LDTs properly assesses a test’s likelihood to detect diseases.
Debate is underway on whether current CLIA review of LDTs properly assesses a test’s likelihood to detect diseases.
Rachel Rangel, AuD, discusses a new toolkit to help laboratory professionals ensure diversity and inclusion is addressed in their research.
The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.