A rapid coronavirus test developed in Brisbane has become the first of its kind to be given emergency approval in the United States.
The US Food and Drug Administration (FDA) approved Ellume's 20-minute COVID-19 Home Test for non-prescription use as it battles soaring cases and deaths from the disease.
The body says the self-test will help reduce the spread of COVID-19 through rapid self-detection, allowing patients to self-isolate instantly.
https://www.drugwatch.com/fda/approval-process/ FDA Medical Device Approval Process The FDA is also charged with evaluating medical devices. Research for medical devices begins in the lab. Most devices undergo laboratory and animal testing to answer basic questions about safety, and then they are tested on people to make sure they are safe and effective.
Most devices undergo animal testing first to answer basic questions about safetyNext, the FDA thoroughly reviews the submitted data and makes a decision whether to approve it. The FDA classifies medical devices based on the risk they pose.
Class I devices are the least risky and include oxygen masks and surgical tools, whereas Class III devices support or sustain life, are implanted in the body or have the potential for unreasonable risk of illness or injury. These include pacemakers, breast implants and HIV diagnostic tests.
Low- to moderate-risk devices are typically subjected to what’s called premarket notification — also called PMN or 510(k). Federal law requires new device manufacturers to register with the FDA and notify the agency at least 90 days before they start selling their devices. This premarket notification must prove the device is as safe and effective and substantially equivalent to a similar, legally marketed device. No evidence from clinical studies is needed. ... Another type of application is for a Humanitarian Use Device, which is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 8,000 people in the U.S. annually. This application is similar to a premarket approval application, but pharmaceutical companies are not required to demonstrate effectiveness.
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