FDA Watch: Agency Takes Steps to Downgrade Some Nucleic Acid-Based Tests to Class II
The change is expected to dramatically cut the costs of developing new tests
FDA-nir
Subscribe today for access to
Articles and Reports
FDA Watch: CND Life Sciences Wins Breakthrough Device Designation for Skin-Based Neurodegenerative Test
The Syn-One assay can diagnose multiple conditions without needing a lumbar puncture
Chevron Doctrine’s Dismissal Has Yet to Upend Regulatory Environment
However, clinical laboratories may have more say in future laws and guidance thanks to 2024 decision
FDA: EUAs for COVID-19 Lab Tests Will Continue after PHE Ends
Agency says it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.
Empowered Dx in Hot Water with FDA Again Over COVID-19 Test Kits
At the end of 2022, the agency sent a new warning letter to Empowered for unauthorized distribution of COVID-19 test kits.
FDA Tightens the Screws on EUA Review of COVID-19 Tests
The agency recently announced subtle but significant changes to its policies governing review of new lab tests for COVID-19.
FDA to Issue Emergency Use Authorization for Monkeypox Tests
In a move to expand access to lab testing for monkeypox, HHS has authorized the FDA to issue EUAs for in vitro diagnostic tests for the virus.
FDA Sounds the Alarm on Counterfeit OTC COVID-19 Tests
Counterfeit COVID-19 tests are being illegally imported into the US and being distributed to unsuspecting consumers across the country.
FDA Sounds the Warning on Use of Unauthorized SARS-CoV-2 Rapid Tests
...
Already a member? Log in here
Don’t Use These Rapid COVID-19 Tests, FDA Warns
The US Food and Drug Administration recently issued a letter warning people not to use two different tests produced by Empowered Diagnostics.
FDA Lists 27 Current COVID-19 Tests that May Not Detect Omicron
...
Already a member? Log in here
HHS Reinstates FDA Premarket Review of LDTs
...
Already a member? Log in here
FDA Expands Recall of Ellume COVID-19 Home Test Kits
...
Already a member? Log in here
