Children’s Hospitals Brace for Reduced Test Access, Higher Costs Under LDT Final Rule

Pathologists at children’s hospitals across the country said that as the premarket review requirements take effect in November 2027 for high-risk LDTs and May 2028 for moderate risk and some low-risk LDTs, they worry that they will become unable to offer new tests to outside patients or modify existing tests to keep up with advances in the field or the replacement of legacy instruments unless they submit those tests for FDA review, which they expect will be a costly and time-consuming process. They also predict that they will similarly lose access to the specialized tests that other hospitals will develop or modify in coming years unless those tests, too, receive the agency’s go-ahead.

Source: https://www.360dx.com/regulatory-news-fda-approvals/childrens-hospitals-brace-reduced-test-access-higher-costs-under-ldt