GOOD HUMAN FACTORS DESIGN FOR HOME-USE DEVICES should be a top priority for manufacturers as more and more products make their way from hospital to home, FDA says. A poorly designed device "is frightening in the hands of a variety of different types of people who don't have expertise and are not adept with the use of devices or machines," says Ron Kaye, FDA's human factors and device-use safety team leader. Proper usability testing is key, and the agency reminds firms that a minimum of 15 subjects should be enrolled in usability studies, though former FDA human factors expert Pete Carstensen advocates even more. "I'll absolutely guarantee you that if you come in with a list of 15 subjects that FDA is going to throw you out the door," he says. Instructions for home devices should be kept simple, and manufacturers should make extra efforts to get information about adverse events that occur in the home. "It's harder for firms to find out what's going on in the home environment, especially if they didn't intend for the device to be used in the home," says Mary Brady, associate director of CDRH's Office of Surveillance and Biometrics.
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In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.
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The US FDA has announced its user fees for fiscal 2026, which are based on a figure of $455,000 for a PMA.
