Regulation of Next Generation Sequencing

TL;DR

The FDA is discussing the regulation of in vitro diagnostic devices and next generation sequencing, outlining their current framework and potential changes for precision medicine.

Transcript

alright thanks to thank you russ and thanks to russ and kathy and natalia and the rest of the Circe team for putting together what's been a really like a really fantastic visit I very excited about the ability to work together going forward I should also say that this is the first time I've ever seen somebody's goal to being to create an FDA presen... Read More

Key Insights

• ⚾ The FDA's regulatory framework for in vitro diagnostic devices provides a risk-based approach to classification and evaluation.
• 🏆 Next generation sequencing tests have various components, some of which are classified as in vitro diagnostic devices, while others are not.
• 🤗 The FDA is working towards developing standards, open-source tools, and quality databases to support the regulation of next generation sequencing tests.

Questions & Answers

Q: What is the legal definition of in vitro diagnostic devices?

In vitro diagnostic devices are reagents, instruments, and systems used for disease diagnosis and health assessment, including determining the state of health for treatment or prevention purposes.

Q: How does the FDA evaluate the different components of next generation sequencing tests?

The FDA considers the device (chemistry, library preparation, sequencing instrument) and software analysis as in vitro diagnostic devices. Interpretation algorithms and software tools for automated interpretation are also classified as devices.

Q: Are there any components of next generation sequencing tests that are not classified as in vitro diagnostic devices?

Manual interpretation, pre-analytical variables, and archiving of results are not considered in vitro diagnostic devices, as they fall under the practice of medicine or data management.

Q: How does the FDA classify devices and what controls are implemented for each class?

Devices are classified into three categories (class 1, class 2, and class 3) based on their risk level. Class 1 devices have general controls, class 2 devices have special controls in addition to general controls, and class 3 devices require premarket application to demonstrate safety and effectiveness.

Summary & Key Takeaways

• The FDA defines in vitro diagnostic devices as reagents, instruments, and systems used in disease diagnosis and health assessment.

• Next generation sequencing (NGS) involves various components that may or may not be classified as in vitro diagnostic devices, depending on their intended use.

• The FDA uses a risk-based approach to classify devices into three categories: class 1 (low-risk), class 2 (medium-risk), and class 3 (high-risk).