(Total Views: 749)
Posted On: 06/18/2018 3:35:16 PM
Post# of 22465
How fast can new nano medical diagnostic tests come to market?
quote-
The FDA policy specified that CLIA waived tests are the simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.
See list of waived tests here:
https://www.meditests.com/clia-waived-tests.html
Moderate and High complexity tests would require more scrutiny.
Nano applications for treatment would require clinical trials in most if not all cases.
quote-
The FDA policy specified that CLIA waived tests are the simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.
See list of waived tests here:
https://www.meditests.com/clia-waived-tests.html
Moderate and High complexity tests would require more scrutiny.
Nano applications for treatment would require clinical trials in most if not all cases.
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