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Notable Changes in the new FDA Draft Guidance – Content of Premarket Submissions for Device Software Functions The FDA released its new draft guidance for the Content of Premarket Submissions for Device Software Functions on November 4, 2021. Once approved, this guidance will replace the preexisting Guidance for the Content of Premarket Submissions for Software […]
In this post, we highlight and summarize parts of the new “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff.” It is important to note that this content contains non-binding guidance and therefore is not currently for implementation. With that said, while […]
> In this blog, we preview our whitepaper “FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready?” Download the entire whitepaper to learn more! FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready? Technology innovation has undergone rapid transformation since the Food and Drug Administration first developed its […]
One of the early steps I advise my clients to take when developing their medical device is to determine the class and classifications of their medical device. In conjunction with the complexity of the device, understanding the class and classification sets the foundation for your product development timeline and effort. This post gives a basic […]