Expert Q&A
CDRH OSEL and DHCoE
FDA’s CDRH OSEL and DHCoE teamed up with ODT’s precisionFDA to design the DEFoGD Challenge. OSEL works to accelerate patient access to safe, effective, and innovative medical devices. The Human-Device Interaction Program in OSEL focuses on addressing regulatory science gaps and challenges related to novel therapeutic, diagnostic, and assistive medical devices. DHCoE works to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.
FDA CDRH: Kimberly Kontson, Vinay Pai, Bray Patrick-Lake, Anindita Saha, Catherine Bahr, Zhengrong Ma, Lauren Rodriguez, Kenny Cha, Aldo Badano, Robert Wright, Tracy Cox, Sabreena Geddie, Anthony Anderson.
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The questions, answers and comments posted under this Expert Q&A forum reflect the views of the author(s) and should not be construed to represent views or policies held by the FDA. Experts answer questions at their discretion and thus not all questions may be addressed. The Expert Q&A forum is also not intended to address questions pertaining to medical advice, diagnosis or treatment.
The questions, answers and comments posted under this Expert Q&A forum reflect the views of the author(s) and should not be construed to represent views or policies held by the FDA. Experts answer questions at their discretion and thus not all questions may be addressed. The Expert Q&A forum is also not intended to address questions pertaining to medical advice, diagnosis or treatment.