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Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

McDermott Will & Schulte

To Market, To Market: FDA’s Digital Health Precertification Program

McDermott Will & Schulte on

In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Strives to Adapt Regulatory Approach to Rapidly Evolving Digital Health Space

Skadden, Arps, Slate, Meagher & Flom LLP on

Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more

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