Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Food and Drug Administration (FDA) has the authority to review medical devices, including LDTs, to ensure they are safe and effective before they are marketed.3 However, to date FDA has not used this authority to regulate LDTs, allowing the devices to flow freely onto the market without premarket approval. [...] R.4128) (VALID), now incorporated into the Senate version of the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022, is presented as a solution to this problem by establishing a risk-based framework for regulating all IVCTs, regardless of where they are produced and used, the current version of the bill unfortunately paves a legal pathway to market for many of these. [...] Grandfathered tests (those on the market prior to the bill’s enactment) Technology certification: In addition to the tiers described above, eligible developers of moderate- or low-risk tests may seek a technology certification order to develop and modify tests within a single technology type or fixed combination of technologies without individual review of each test. [...] A developer must submit information to show that eligible tests within the scope of the certification will meet the applicable standard, including information showing that covered tests will conform to the applicable quality requirements, procedures for analytical and clinical validity, and procedures for establishing that tests are safe. [...] This standard runs counter to the advice offered by FDA in the agency‘s 6 Technical Assistance (TA), which advised that test developers document a test’s validity, safety, and the truthfulness of claims, and provide this documentation to the agency on request.22 o Recommendation: In line with the FDA’s TA, a test developer should be required to maintain, and provide to the agency on request, docum.
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