Recognizing that its traditional approach to device regulation is not well suited for the rapidly developing digital health sector, the Food and Drug Administration (FDA) has in recent years put forth a concerted effort to better understand this growing area and to establish a regulatory paradigm that is tailored for digital products. With the recent passage of legislation and with FDA’s own efforts, a picture of how digital products may be regulated in the future is beginning to emerge. However, many questions remain, and digital health companies must still navigate an uncertain and evolving regulatory path.
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