Chapter
Designation of Public Health Tools during COVID-19
26:03 - 32:31 (06:27)
The FDA does not authorize or review public health tools or tests for COVID-19. However, in light of the public health emergency, any tools used for testing during this time will be designated as public health tools.
Clips
The FDA's only job regarding rapid COVID-19 tests is to authorize them as medical devices, leaving companies no choice but to apply for medical claims rather than alternative claims.
26:03 - 28:19 (02:15)
FDA, COVID-19
Summary
The FDA's only job regarding rapid COVID-19 tests is to authorize them as medical devices, leaving companies no choice but to apply for medical claims rather than alternative claims. This can lead to skewed clinical trials, which is not good practice.
ChapterDesignation of Public Health Tools during COVID-19
Episode#235 – Michael Mina: Rapid COVID Testing
PodcastLex Fridman Podcast
The FDA does not review or authorize public health tools and tests for COVID-19, which are designated as public health tools during the pandemic.
28:19 - 32:31 (04:11)
FDA, public health tools, COVID-19
Summary
The FDA does not review or authorize public health tools and tests for COVID-19, which are designated as public health tools during the pandemic. The FDA has a confusing view on this, and calling them public health tools could result in them being labeled as illegal.