How does corrective and preventive action (CAPA) ensure the ongoing safety and effectiveness of medical devices?

Technically, the FDA does not “approve” medical devices or IVDs for sale under the FDA 510(k) premarket notification process. The FDA gives “clearance” for them ... Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. ... The phrase “substantially equivalent” means your ... Jan 4, 2023 ... • it is marketed without a 510(k) clearance (when applicable);. • a restricted device uses false or misleading advertising or is sold ... Mar 17, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, "This FDA 510(k) clearance is a defining moment for Monogram ... Jan 24, 2023 ... What does this all mean for you? It means we did the work to ... What that means: A 510(k) filing contains detailed technical, safety ... Sep 19, 2022 ... The 510(k) approval process is an FDA requirement for medium-risk medical devices such as self-fitting hearing aids. Aug 4, 2022 ... “When Xoran states that TRON is the 'One RING to rule them all,' we truly mean that this compact, mobile, open-bore device is poised to ... Apr 11, 2023 ... A 510(k) clearance means that FDA has completed its review of the 510(k) review and determined that the device is substantially equivalent to an ... Feb 8, 2024 ... For comparison, the FDA mean review times were 150 days for 510(k)s ... And the 510(k) clearance pathway is generally easier and faster. 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 ...