The FDA has made continuous strides to set the foundation for how it will regulate digital health products like AI/ML devices, virtual reality devices, and various types of wearables. From its Digital Health Center of Excellence, to various discussion papers and guidance documents regarding these novel technologies, it’s no secret that the Agency is still in the infancy stages of determining a robust regulatory framework as the industry advances at lightning pace.
To counteract this, the FDA has started to turn towards the industry itself for its expertise. Last week the FDA announced it is establishing a digital health advisory committee to increase its understanding of the benefits, risk, and clinical implications of digital health technologies. [1] The committee will consist of nine members, including a committee chair, all selected by the FDA commissioner or designee.
The nine members will consist of Agency representatives, as well as industry technical and scientific experts. The main objective of the committee is to further the Agency’s understanding of the technology, while also fulfilling its duty of protecting public health. By turning to the industry itself to take the driver’s wheel in advancing the regulatory conversation, the FDA hopes that it will expedite formalizing regulatory framework.
The industry will have a better understanding of risks and potential unintended consequences than the FDA will have from a surface level review. This committee will also bring a first-person perspective to the conversation. As the people who are actually developing these technologies, they will also understand what the future may hold when it comes to advancing healthcare.
Virtual reality, for example, is not just for flashy consumer products or innovative new video games. More and more medical device firms are introducing virtual or augmented reality into their products to simulate situations like operating rooms or even bring another dimension to telehealth. In addition, pharmaceutical companies are also beginning to explore AI/ML algorithms to conduct research and expedite development of novel drugs. With all of the ways that software is taking over the MedTech ecosystem, its imperative that the FDA stay ahead of the wave.
If you need support with your digital health product and understanding where you stand in the ongoing regulatory conversation, EMMA International is here to help! Call us at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.
[1] FDA (Oct 2023) FDA Digital Health Advisory Committee retrieved on 10/15/2023 from: https://www.fda.gov/medical-devices/digital-health-center-excellence/fda-digital-health-advisory-committee?utm_medium=email&utm_source=govdelivery
