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The National Law Review7y
FDA to Expand Abbreviated 510(k) Pathway for Medical Devices by Allowing Comparison to Performance Criteria
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation ...
JD Supra1y
Modernizing the FDA’s 510(k) Program for Medical Devices: Selection of Predicate Devices and Use of Clinical Data in 510(k) Submissions
On September 6, 2023, the US Food and Drug ... chart to summarize assessments involving the best practices. Finally — and notably — the FDA recommends that submitters include within their 510 ...
PharmiWeb3mon
Navigating FDA 510(k) Approval with Proregulations' Services
The FDA review of 510(k) is focused on a comprehensive comparison of the application and the selected predicate device, especially the product design, materials, performance, and intended use. 510(k) ...
STAT1y
FDA proposes changes to key approval pathway for medical devices, five years after promising
Last week, the FDA released a trio of guidelines clarifying the way it plans to evaluate devices that go through the 510(k) pathway ... should submit flow charts explaining why they chose their ...
Nasdaq5mon
Intelligent Bio Solutions Inc. Submits FDA 510(k) Application for Intelligent Fingerprinting Drug Screening System
Intelligent Bio Solutions Inc. (INBS) has submitted a 510(k) premarket notification to the FDA for its Intelligent ... including a method comparison study that demonstrated the System’s 94.1 ...
Medical Device Network on MSN12d
FDA grants 510(k) clearance to Fujirebio’s blood-based test for Alzheimer’s
The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 ...
STAT2y
An FDA pathway to clear medical devices is putting patients at risk, research suggests
But the FDA also approves devices including artificial joints, infusion pumps, and scalpels using a process known as the 510(k) pathway ... was cleared using a comparison to the recalled device.
Stryker Gets FDA 510(k) Clearance for OptaBlate System
Stryker said Monday that its OptaBlate basivertebral nerve ablation system received 510 (k) clearance from the Food and Drug Administration. The medical technology company said its OptaBlate BVNA is ...