Did you know? The US Food and Drug Administration (FDA) has set yet another high record by approving 106 novel devices in 2018, making it the most successful year for medical devices. With this accomplishment, FDA has surpassed its 40-year old record set in 2017 of approving 99 novel devices, showing a continuous growth for the past 8 years.
March 7, 2019 Medical Devices
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.
November 5, 2018 Medical Devices
Registering a medical device with the FDA requires an apt submission pathway. In most of the cases, identifying and selecting a pathway is quite simple. For example, as discussed in our previous blog, if there exists a predicate for your medical device, then file a 510(k).
September 27, 2018 Medical Devices
Currently valued at $156 billion, the USA is the largest market for medical devices in the world representing approximately 40% of the global market. Given the scenario, manufacturers are on constant look out to market their products in the region. Enroute, even a small error in the approach can result a device recall.
November 29, 2017 Medical Devices
Are you deciding on when to submit a 510(k) for a change to an existing device? As we have reported earlier, the US Food and Drug Administration (FDA) has finalized the guidelines on changes in medical devices that would need a 510(K) submission.
The guidance is expected to aid manufacturers of:
September 29, 2017 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.