How does the FDA handle the issue of off-label use of 510(k) cleared devices?

Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance. JAMA. 2023 Jan 10; ... Public documents for the 510(k) medical devices were collected using FDA ... Jan 30, 2025 ... In addition to the clearance, AI Optics is ... A total of 196 patients (48.5% women; mean age, 61 years) were identified who had been referred for ... To receive FDA approval on a new device intended for human use, a premarket submission called a 510k must be made to the FDA. This must demonstrate that the ... Aug 22, 2022 ... The step means that Nerve Tape's development partner, Atlanta ... Nerve Tape is the company's first FDA-cleared medical device and ... FDA 510(k) Medical Device Clearance. The 510(k) pathway is based on ... A claim of substantial equivalence does not mean the device(s) must be identical. Mar 17, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, "This FDA 510(k) clearance is a defining moment for Monogram ... Jul 21, 2016 ... The INTRACEPT System is the first specific therapy to relieve chronic low back pain (CLBP) of at least six months duration that has not responded to at least ... Following is a breakdown of 510(k) exempt and Good Manufacturing Practice ... FDA is taking this action in order to meet requirements of FDAMA and the ... Mar 21, 2022 ... Developing a new medical device? Here's how much time and cash it could take to get FDA 510(k) clearance or De Novo classification. May 29, 2024 ... This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a ...