How can digital health companies successfully take their AI-based products through the regulatory pathways in the US? What is the best regulatory pathway for their solution?
Our members often ask these questions in our meetings, seeking advice and best practices in their regulatory strategies in the US. They often struggle in the process. How can they think of their regulatory approach as a product and company strategy rather than an obligation?
Here are some essential things to know about the regulatory considerations for AI-based solutions in the US.
Remember: The best practices for working with the FDA are to have a positive mindset and drop the fear of the FDA. It is also important to answer the FDA’s feedback and provide rational alternatives if required. Know your development strategy but be open to flexibility, have a clear purpose for your product, and be very specific about it.
Aligning clinical, regulatory, and marketing strategies is a cross-functional effort, bringing the stakeholders together at the table and having one comprehensive path to the market is the key to success. Once the marketing clearance is granted, the regulatory path is an ongoing process of keeping the FDA informed of new clinical and health economics studies.
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