FDA Watch: Agency Restructures Submission Protocols for Several ISH Tests
The FDA is reclassifying product codes NYQ, MVD, OWE, and PNK so they can be approved using the 510(k) submission process
Already a member? Log in here
FDA-lir
Subscribe today for access to
Articles and Reports
FDA Watch: Labcorp Gets Companion Diagnostic Approval for Advanced Melanoma Test
Company also announces distribution of newly approved Alzheimer’s assay
Already a member? Log in here
FDA Watch: OraSure’s Collection Device for Cobas STI Testing Receives Approval
At-home sample collections can be mailed to a clinical laboratory
Already a member? Log in here
Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs
...
Already a member? Log in here
FDA Watch: VALID and VITAL Bills for LDTs Regulation Are Back in Play
...
Already a member? Log in here
First Ever Approval of COVID-19 Blood Spot Self-Collection & Molecular Test Pooling
...
Already a member? Log in here
Manufacturers Wait Anxiously for CMS Decision on Automatic Medicare Coverage of MCIT Breakthrough Devices
...
Already a member? Log in here
Agency Okays COVID-19 Blood Spot Self-Collection & Molecular Test Pooling
...
Already a member? Log in here
Manufacturers Wait Anxiously for CMS Decision on Automatic Medicare Coverage of MCIT Breakthrough Devices
...
Already a member? Log in here
Agency Okays COVID-19 Blood Spot Self-Collection & Molecular Test Pooling
...
Already a member? Log in here
Agency Opens Premarket Pathway for Post-Emergency COVID-19 Test Marketing
...
Already a member? Log in here
Agency Clears Record Number of New Medical Devices in 2020
...
Already a member? Log in here
Ortho Clinical Diagnostics Gets Green Light for Mass SARS-CoV-2 Antigen Test
...
Already a member? Log in here