Approval for OTC use of a urine drug test that can be performed by non-CLIA facilities could help expand accessibility, expert says.
The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
With recent test recalls announced by Universal Medtech and QuidelOrtho, such products now make up one-third of 2023 total recalls listed by the FDA.
The agency recently sent its own proposed LDTs regulation rule to the White House Office of Information and Regulatory Affairs for review.
New program aims to provide greater transparency on the recommended performance characteristics of such tests.
The agency recently announced it will decide in December whether to grant clearance for a CRISPR therapy for treating sickle cell disease.
In early May, GSK’s Arexvy became the first RSV vaccine to be cleared by the FDA for use in the US in adults aged 60 and up.
On March 27, the agency released a new guidance document to help test developers make the transition to full approval.
In the period from Mid-February through mid-March, three different products received first-of-their-kind clearances from the agency.
According to the FDA’s recently-released annual report, only 135 devices received the designation last year, versus 213 in 2021.
The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.
In this month’s diagnostics pipeline report, Roche gets clearance for two new Alzheimer’s early detection tests.