Clinical
The FDA will begin regulating laboratory-developed tests (LDTs), it announced at the end of July. To present, the agency has used “enforcement discretion,” and generally not imposed regulation on LDTs, despite their being considered medical devices. According to the FDA, changes in the LDT market over time without oversight might now expose patients to risk. Causes of risk include manufacturing on large scales or using components not approved for clinical use, testing for common diseases or on nonlocal populations, basing treatment decisions on test results and test complexity. Like other medical devices, LDTs would be subject to classification (Classes I, II or III), and six months after finalization of the FDA guidance, manufacturers would have to inform the agency of tests they are developing and any “significant adverse events.” Regulation would be phased in according to risk and agency resources, beginning 12 months after finalization. Third-party review for some LDTs would be required, and support for test validity, either via studies or the support of clinical literature, as well as adherence to the Quality System Regulation for test design and manufacture would be necessary.
Source: FDA