FDA’s Response to Data Integrity Issues The FDA recently expressed concern regarding the rise of fraudulent and unreliable laboratory testing data in premarket submissions. The agency…
FDA’s Proposal for LDT Regulation In a collaborative effort to enhance the safety and effectiveness of Laboratory Developed Tests (LDTs), the Food and Drug Administration (FDA)…
As we step into the new year, we asked our team members to share their insights by forecasting five daring trends in medical device quality for…
Rook Quality Systems (RookQS), a leading provider of quality solutions, is proud to announce its strategic partnership with Trust Cybersecurity, a specialized cybersecurity testing service catering…
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…
![Steps the FDA Continues to Take to Strengthen the Premarket Notification [510(k)] Program](https://rookqs.com/wp-content/uploads/2023/10/9.23.23-Blog-Image-scaled.webp)
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…