In the last few Map of Biomedicine blog posts I’ve talked about several different ways that diagnostic products can get to market. Laboratory-developed Tests (LDTs) and tests that get 510(k) approval (for tests that are similar to existing tests) are two ways.
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Tags: map of biomedicine, diagnostic test development, 510(K), LDT, PMA, Premarket Approval
In my last post, I talked about the laboratory-developed tests (LDT), or “home brews.” LDTs are run in individual labs whose operations are regulated under Clinical Laboratory Improvement Amendments (CLIA). The home brews, however, are essentially unregulated, except in the sense that physicians and hospitals won’t recommend tests that aren’t good for their patients.
Tags: map of biomedicine, diagnostic test development, 510(K), LDT, PMA