Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
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.
A roundup of the significant new diagnostic tests and products that received regulatory approval in the US and around the world.
In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.
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 has once more gotten the jump by becoming the first company to get EUA clearance for a commercial monkeypox RT-PCR test kit.
Despite lessons learned from COVID-19 testing, HHS and FDA plan for monkeypox testing remains flawed.
The agency is advising people to perform repeat, or serial testing after a negative result, regardless of symptoms.
In a recent report, the GAO says the agency needs a policy when it comes to enforcement discretion regarding tests approved via EUA.