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Pharma, device groups oppose FDA’s planned drug to device transition

May 04, 2022 On 9 August 2021, FDA published a notice announcing its implementation of a court decision in Genus Medical Technologies LLV v. FDA (Genus) and requesting public comment.  The notice states that in accordance with the Genus decision, FDA “intends to regulate products that meet both the device and drug [emphasis original] definition … Read more

FDA warns that some prenatal screening tests can generate false results

April 29, 2022 The growing – and sometimes inappropriate – use of these tests prompted the warning, according to FDA.  These tests, which fall under the category of laboratory-developed tests (LDTs), are not subject to premarket review by FDA and are accorded enforcement discretion under the Medical Device Amendments of 1976. “While genetic non-invasive prenatal … Read more

UCF researchers develop new rapid test to detect viruses like COVID-19

April 26, 2022 Researchers at the University of Central Florida (UCF) in the US have developed a device to identify viruses, such as COVID-19, in the human body as quickly as rapid detection tests.  The new device has a 95% accuracy rate for determining if a person carries a virus, a claim that matches the … Read more