HP&M Files Comments Opposing FDA’s Proposed LDT Rule
FDA Law Blog
DECEMBER 6, 2023
For example, in FDA’s “primary” case, laboratories would be expected to spend eight hours a year on management reviews. Part 11, the need to hire new laboratory personnel, and engage outside experts such as Contract Research Organizations, biostatisticians, lawyers, and software engineers. FDA seems unconcerned by this prospect.
Let's personalize your content