When bringing a DHT to market, digital health developers must ensure it meets all necessary regulatory requirements to enable patient access and maximize its full potential. A robust regulatory strategy ensures that DHTs are safe, effective, and meet the necessary quality standards and trust of patients, clinicians, and payers.

To help you implement strategies that account for the positive impact of US regulatory engagement on your products’ commercial success and patient access, these industry case studies illustrate how organizations have successfully engaged with the FDA to gain the necessary authorizations to bring their digital health products to market.