A Guide to Etiquette and Preparation for Your First FDA Audit
Mastering Your First FDA Audit: A Guide to Etiquette and Preparation Following the COVID-19 pandemic, there has been a significant increase in FDA inspections as inspectors…
Guidelines for Verifying Laboratory Testing Data Before FDA Submission
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 Proposes New Regulations For Laboratory Developed Tests
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)…
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…
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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…