00062 VALID Act: Near-Patient Testing Guidance

00062 Near-Patient Testing Guidance

VALID Act

“(3) NEAR-PATIENT TESTING.—Not later than 1 year after the date of enactment of the Verifying Accurate Leading-edge IVCT Development Act of 2021, the Secretary shall issue draft guidance indicating categories of tests that shall be exempt from premarket review under section 587B when offered for near-patient testing (point of care), which were not exempt from submission of a report under section 510(k) pursuant to subsection (l) or (m)(2) of section 510 and regulations imposing limitations on exemption for in vitro devices intended for near-patient testing (point of care).