Laboratory-developed tests: the need for regulation
![Person putting a drop in a test tube](/sites/default/files/styles/700x530/public/2024-04/louis-reed-pwcKF7L4-no-unsplash_0.jpg?h=0d27ee61)
Louis Reed - Unsplash.com.
The FDA has the authority to review medical devices, including lab-developed tests. However, to date FDA has not used this authority to regulate LDTs, allowing the devices to flow freely onto the market without premarket approval.