It's kind of shocking, when it comes to how irresponsible it is. It's emblematic of a desire to, essentially, increase corporate power.
Department of Health and Human Services
- page 455
… Process for Laboratory-Developed or Modified Medical Tests. Learning from the failed early COVID -19 testing … focus on reforming laws and regulations governing medical tests, especially with respect to laboratory-developed tests. Chapter Department of Health and Human Services Page … - page 456
… Commercial tests are developed with the - 6418 Commercial tests are developed with the intention of being widely … marketed, distributed, and used, while laboratory-developed tests are created with the intention of being used solely … - page 456
… The “laboratory-developed tests” category currently encompasses - 6420 The “laboratory-developed tests” category currently encompasses a range of possible tests, many of which would be characterized more … - page 457
… has long held that it has regulatory authority over such tests, while others have argued that they should be … to clarify and disentangle overlapping authorities over tests to eliminate regulatory confusion." Chapter Department … has long held that it has regulatory authority over such tests, while others have argued that they should be … - page 457
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