FDA Submission
OIG: FDA recommendations for future pandemics
September 21, 2022
Cue Health requests FDA de novo clearance for at-home flu test
September 1, 2022
FDA issues updated reagent, instrument guidance
August 15, 2022
Natera files presubmission with FDA for NIPT test
August 10, 2022
Abionic nabs IVDR certification for sepsis test
August 8, 2022
I-calQ receives 9th patent for smartphone POC testing
January 14, 2021
Most Popular
MDIC releases IVD regulatory decision-making framework
August 23, 2020
HHS: FDA review not needed for coronavirus LDTs
August 19, 2020
Abbott unveils lab-based COVID-19 antibody blood test
April 15, 2020
Myriad files companion BRCA test in prostate cancer
January 20, 2020
FDA moves to electronic-only device submissions
December 12, 2019
FDA airs 'to do' list for devices in 2020
October 13, 2019
Page 1 of 2
Next Page