US FDA publishes new guidelines with focus on digital health

The FDA’s Center for Devices and Radiological Health (CDRH) has published its FY2023 guidance priority lists. Digital health is a major focus of the center’s current fiscal year. FDA said it will publish several digital health guidances, including one for medical device cybersecurity quality system considerations. It will also publish one for device software functions and another addressing change control plans for products with artificial intelligence/machine learning software.
In recent years, regulators and industry have become more concerned with the issue of change control plans, as the agency has repeatedly updated its premarket and postmarket cybersecurity guidance. In the latest user fee reauthorization bill, some lawmakers tried to include a rider that would give FDA explicit authority to allow change control plans. This is a top priority for the medical device industry when Congress passes an omnibus budget bill later this year. Some legal experts, however, support the agency’s assessment that it already has the authority to allow change control plans in a white paper.

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