What is A Pre-Submission (Pre-Sub)?
A Pre-Submission (Pre-Sub) is a type of Q-Submission used by medical device developers to seek feedback from the FDA on applications such as IDE, PMA, HDE,…
FDA Labeling Requirements for Point of Care vs. Home Use Devices
A critical decision in designing and developing a medical device is whether it will be used by trained professionals or the general population. This decision will…
Navigating the FDA’s Final Rule on Lab-Developed Tests – LDTs
On April 29th, 2024, the FDA introduced its much-anticipated Final Rule on Laboratory Developed Tests (LDTs), marking a significant milestone in regulating in vitro diagnostics. This…
Streamlining Success: Rook Quality Systems’ Comprehensive Clinical Evaluation Services for Medical Device Clients
Rook Quality Systems offers comprehensive clinical evaluation services to medical device clients, assisting clients with navigating the development and regulatory approval process. Our strategy emphasizes the…
A Guide to Etiquette and Preparation for Your First FDA Audit
Mastering Your First FDA Audit Following the COVID-19 pandemic, there has been a significant increase in FDA inspections as inspectors strive to catch up with the…
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…