Understanding the FDA Changes to LDT Regulations
This post is part of a two-part series. You can read Part 1 here In the ever-evolving landscape of medical technology, the regulation of Laboratory Developed…
This post is part of a two-part series. You can read Part 1 here In the ever-evolving landscape of medical technology, the regulation of Laboratory Developed…
Why did the FDA release this document? The guidance document “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring” introduces a new policy…
What does the FDA consider to be a wearable medical device? The difference between the two classifications of wearable devices and general wellness devices can severely…
This post is part of a two-part series. You can read Part 2 here. Per the FDA commissioner, Dr. Robert M. Califf, and data from the…
Last week, the U.S. Food and Drug Administration (FDA) released three new draft guidances to strengthen the 510(k) program and to advance the safety and effectiveness…
Artificial intelligence (AI) is changing the world and the medical device realm, but in reality, it is a simple word: automation. In this blog post, we…
On June 14, 2023, the FDA released their final updated guidance document on the Content of Premarket Submissions for Device Software Functions. The document is the…
What is SaMD? SaMD stands for Software as a medical device. Software as a medical device is any software intended to be used for one or…
When medical devices are user-friendly there is a higher probability for users to continue using the device for clinical or personal purposes and highly recommend the…
With the new year upon us, we asked our Founder/President, Kyle Rose, and our General Manager (Taiwan Branch), Andrew Wu, to peer into their respective crystal…