Home pregnancy test studies should include 100 urine specimens -- FDA guidance.
This article was originally published in The Gray Sheet
HOME USE PREGNANCY TEST 510(K)s BASED ON AT LEAST 100 SAMPLES are recommended by FDA in a draft guidance document released Sept. 29. In addition to over-the-counter human chorionic gonadotropin (hCG) pregnancy tests, the guidance covers professional-use hCG pregnancy tests.
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