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editorial
. 2020 May 30;21:e00172. doi: 10.1016/j.plabm.2020.e00172

Table 1.

Timeline of key developments in the regulation of laboratory testing.

Date Document Relevant Statute
1976 Medical Device Regulation Act Food, Drug, and Cosmetic Act of 1938
1998 Clinical Laboratory Improvement Amendments (42 USC 263a) Public Health Services Act
2014 Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) Food, Drug, and Cosmetic Act of 1938
2017 Diagnostic Accuracy and Innovation Act (DAIA) Food, Drug, and Cosmetic Act of 1938
2018 Verifying Accurate Leading-edge IVCT Development Act of 2018 (FDA technical assessment of DAIA) Food, Drug, and Cosmetic Act of 1938
2019 Verifying Accurate Leading-edge IVCT Development Act of 2018 (FDA technical assessment of DAIA) Food, Drug, and Cosmetic Act of 1938
March 2020 Verifying Accurate Leading-edge IVCT Development Act of 20201 Food, Drug, and Cosmetic Act of 1938
March 2020 Verified Innovative Testing in American Laboratories Act of 2020 Food, Drug, and Cosmetic Act of 1938