How can manufacturers work with the FDA to resolve compliance issues and avoid enforcement actions?

Apr 2, 2024 ... Designed for symptomatic individuals within six days of symptom onset, the QuickVue COVID-19 test is cleared for use in individuals aged 14 or ... Jan 4, 2023 ... • it is marketed without a 510(k) clearance (when applicable);. • a restricted device uses false or misleading advertising or is sold ... Jan 12, 2024 ... The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means termination of medical device Emergency Use ... It is important to seek feedback from FDA at a time when it will be of most value. o Initiating a pre-submission meeting early might mean that you still have ... Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, and the ... Jun 26, 2018 ... A myth that has regrettably gained some traction lately is that the FDA's clearance of a medical device under the 510(k) substantial ... 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 ... 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 ... Nov 30, 2020 ... The 510(k) regulatory clearance pathway is used to demonstrate to the FDA ... Notably, “substantially equivalent” does not mean identical! 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 ...