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…
FDA’s Move to Lower 510(k) Submissions to Aid Virtual Health Care
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…
Road to Market for Wearable Medical Devices
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…
The Future Regulation of Laboratory-Developed Tests (LDTs)
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…
Steps the FDA Continues to Take to Strengthen the Premarket Notification [510(k)] Program
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…
Where does AI meet the Medical Device Industry?
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…
FDA Releases Updates on Software Guidance
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…
The Partnership Continues: Greenlight Guru to offer RookQS SaMD Templates
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…
How to Prepare Human Factors Documentation for the FDA Premarket Submission
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…
5 BOLD Predictions for Medical Device Quality in 2023
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…