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Jones Day

FDA on Board With Continuing Remote Inspections

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The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

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The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Goodwin

FDA Issues Draft Guidance for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

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The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

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