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Agreed with Michael. Check out EU Regulation 207/2012 specifically Articles 3 and 5. They discuss scenarios in which manufacturers may provide eIFU rather than paper form for certain devices (Article 3) and for certain conditions (Article 5). ------------------------------ Lawrence Maddela Regulatory ...

Assuming your device is subject to either PMA, 510(k), or de novo, it can be designated as a Breakthrough Device as long as both of the following criteria are met: 1) The device is shown to be more effective in treating or diagnosing a certain disease/condition. 2) The device meets AT LEAST one of ...

If the clinical data you collected from the prototypes can demonstrate technical, biological, and clinical equivalence to your device, then that would be sufficient and you wouldn't need to do more of conducting a clinical investigation. Be aware, however, it's not always that bench testing is sufficient ...

To add on to Ginger's point, I know former FDA Commissioner Scott Gottlieb suggested limiting predicate devices to those cleared within the last 10 years. His statement from November 2018 (from FDA website): "Older predicates might not closely reflect the modern technology embedded in new devices, ...

Hi Anon, Clinical trials are generally not required for 510(k) devices. Have you identified a predicate device? If your wearable device cannot be shown to be as safe and effective as the predicate through appropriate testing, then you may need to do clinical studies (and therefore would need IRB approval). ...