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The 438tr refers to a specific form used in the FDA regulation process, which may relate to a type of report or application. 23andMe is a personal genomics company that provides DNA testing and analysis services.
Entities or individuals who are involved in genetic testing and who wish to market their tests or provide services related to the FDA regulations may be required to file the 438tr.
Filling out the 438tr involves providing accurate data regarding the genetic tests, including scientific information, testing methodologies, and compliance with regulatory standards set by the FDA.
The purpose of the 438tr is to ensure that genetic tests comply with FDA regulations, safeguarding public health and ensuring that tests are reliable and accurate.
Information reported may include test methodologies, clinical validity data, risk assessments, and details about the genetic variants being tested.
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