Stephanie Philbi from Goodwin Procter LLP Author Profile Page

Stephanie Philbi

Goodwin Procter LLP

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Compliance Food, Drugs, Healthcare, Life Sciences

FDA Issues Draft Guidance For Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

04 May 2023 | United States

FDA Issues Guidance Document On Animal Studies For The Evaluation Of Medical Devices

03 Apr 2023 | United States

Top 5 Compliance Issues For Medtech Firms Transitioning To Data-Enabled Solutions (MedCity News)

01 Feb 2023 | United States

Avoiding Misbranding: Words Matter When Describing The Regulatory Status Of 510(k) Cleared Devices And Registered Device Establishments

24 Nov 2022 | United States

FDA Announces Total Product Life Cycle Advisory Program (TAP) Pilot

11 Nov 2022 | United States

FDA Issues Final Clinical Decision Support Software Guidance

21 Oct 2022 | United States

Potential AI/ML Learnings To Come From FDA Public Advisory Committee Meeting On Skin Lesion Analyzer Technology In Late July

23 Jun 2022 | United States

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