It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTs
FDA Law
AUGUST 3, 2022
3, 1992) (“It has come to the attention of FDA that laboratories have been manufacturing, “home brew” products, either from products already on the market, or from components, and utilizing these unapproved products for diagnostic purposes. These products are subject to the same regulatory requirements as any unapproved medical device”).
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