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Sheppard Mullin Richter & Hampton LLP

FDA Releases Long-Anticipated Guidance on Predetermined Change Control Plans for Devices That Utilize AI/ML Software

Sheppard Mullin Richter & Hampton LLP on

FDA’s primary challenge in regulating AI-enabled device software functions (“AI-DSF”) has been that the self-modifying nature of these functions simply does not fit within the Agency’s long-standing framework for medical...more

Hogan Lovells

Guidances galore: FDA finalizes multiple digital health guidance documents

Hogan Lovells on

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released a series of guidance documents addressing the agency's current views on software regulation following the changes implemented in the 21st...more

Hogan Lovells

Clarifying Digital Health and Software Regulation: FDA Releases Three New Guidance Documents

Hogan Lovells on

On December 7, 2017, the Food and Drug Administration (FDA or the Agency) released three guidance documents that together aim to clarify the framework for the regulation of software and digital health products to bring FDA...more

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