Roche Scores First European IVDR Approval for Diagnostic Tests
The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.
FDA-dtet
Subscribe today for access to
Articles and Reports
Latest Articles
Roche Alzheimer’s Early Detection Tests Get FDA Green Light
In this month’s diagnostics pipeline report, Roche gets clearance for two new Alzheimer’s early detection tests.
December 2022 FDA Watch: COPD, COVID-19, and MDD Tests Gain Clearance
A roundup of the significant new diagnostic tests and products that received regulatory approval in the US and around the world.
November 2022 FDA Watch: Pace of New Approvals Slows
Though there were fewer new approvals last month, the impact of the products that did gain approval more than made up for the drop in volume.
Abbott Ushers Monkeypox Testing into Its New Commercial Phase
Abbott has once more gotten the jump by becoming the first company to get EUA clearance for a commercial monkeypox RT-PCR test kit.
FDA Reopens EUA & Immediate EUA-Less Use Pipelines for Monkeypox Tests
Despite lessons learned from COVID-19 testing, HHS and FDA plan for monkeypox testing remains flawed.
Repeat At-Home COVID-19 Antigen Tests to Avoid False Negatives, FDA Says
The agency is advising people to perform repeat, or serial testing after a negative result, regardless of symptoms.
GAO: FDA Needs Policy to Avoid Repeating EUA COVID-19 Test Mistakes
In a recent report, the GAO says the agency needs a policy when it comes to enforcement discretion regarding tests approved via EUA.
FDA Re-Opens Door to Pre-Submission Requests for Non-COVID-19 IVD Tests
The move comes shortly after the FDA said it was going to decline some pre-submission requests to focus on pandemic-related diagnostics.
Medical Device User Fees Agreement Finally Nearing the Finish Line
Though it took longer than expected, the medtech industry and FDA have finally agreed on medical device user fees for the next five years.
FDA Lays Out New Guidelines for Medical Device Cybersecurity
With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.
InspectIR Nabs First FDA Approval for a SARS-CoV-2 Breathalyzer
On April 14, the FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
New Deal Reached for MDUFA Medical Device User Fees
The FDA’s Center for Devices and Radiological Health says that the agency and industry have reached agreement on MDUFA V.
