The United States Food and Drug Administration (USFDA), to enhance the submission process for medical devices, has introduced a final rule to replace the paper submissions with electronic submissions. The rule which was proposed in September 2018 is expected to come into effect in 2020. The final rule is aimed at improving the device's premarket submission program and targeted towards making the medical device submission process more efficient.
Every year, FDA regulates more than 190,000 medical devices pertaining to different classes. In order to provide better healthcare, the agency is striving continuously to update the pathways through which these devices are being submitted. In a recent press release, FDA announced that the agency is looking at the potential aspects to update the 510(k)-clearance pathway for medical devices.
The US Food and Drug Administration (FDA) has announced that it may release finalised guidelines for the device changes that would need a new 510(K) submission before 8th November, 2017. Rooting to the guidance documents released in 2016 and to clarify some of the questions raised through the comments received, the aim of the recent FDA announcement is to make the terminology consistent by providing precise examples.