The agency issued a rule that brings new scrutiny to a range of critical lab-developed tests, including certain cancer and prenatal screenings. ProPublica previously reported how lab-test accuracy and marketing had skirted federal oversight.
Scores of critical lab tests fall into a regulatory void. The FDA is trying to close it.
Lab-developed tests like prenatal screenings have become increasingly popular, all while escaping the bulk of federal scrutiny over marketing and accuracy. Now, the FDA is beginning the process of imposing regulations on these kinds of tests.
The tests are vital. But Congress decided that regulation is not.