The Evolving Regulatory Path for DTx: Jason Brooke Shares Insights on 510(k), De Novo, PMA and International Classification Processes for DTx
Join me for this conversation with M. Jason Brooke, MSE, JD, CSQE, Attorney and Managing Member of Brooke Consulting LLC. Brooke Consulting is a digital health legal and regulatory advisory firm. Jason offers a unique, multi-disciplinary perspective on the digital health industry as a regulatory attorney, scientist, technologist, and quality consultant.
Jason and I talk about the three main pathways through the FDA: the 510(k) process, De Novo process and PMA (Premarket approval) process. We discuss the pros and cons of each pathway, and the requirements for testing and clinical data. Jason also explains the types of different types of testing such as verification and validation (bench top) testing, non-clinical animal testing, and clinical testing. But what about cybersecurity and biocompatibility which may be required for some SaMD (Software as a Medical Device) and sensors used in DTx solutions? Yes, Jason shares some insights on that as well!
In this episode, we cover:
- Key milestones over the past 10 years for the DTx industry from a regulatory perspective
- Pros and cons of pursuing one of the three main pathways for FDA approval for a DTx
- Jason’s opinion about what is currently missing with DTx SaMD regulation to uphold it to the same standard as a medical device
- Comparisons of the regulatory developments in the US to other areas of the world (EU, APAC)
- The future of regulatory frameworks for DTx
- Predictions and suggestions for regulators as the DTx industry moves forward
Guest Links and Resources:
- Connect with Jason Brooke on LinkedIn
- FDA Information about Sofware as a Medical Device (SaMD)
- Visit Brooke Consulting’s website
Jason Brooke brings a focused expertise in the medical device industry that combines nearly 20 years of experience ranging from science and technology design, development, implementation, and testing; to business strategy and operations; to legal and regulatory compliance. Jason has conducted scientific research (pre-clinical and clinical) and technology development in academic and industry environments as a biomedical engineer, worked within the FDA’s Center for Devices and Radiological Health as a regulatory affairs program analyst, counseled clients as an attorney and consultant focused on the medical device and digital health space, and served as the chief executive officer, general counsel, and vice-president of regulatory and quality for small medical device companies.
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Season 2 of Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:
> Presenting Partner: Amalgam Rx
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