FDA Launches the Digital Health Center of Excellence - FDA.gov

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According to the FDA press release:

"Today, the U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence is an important step in furthering the agency’s overarching dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.

“Establishing the Digital Health Center of Excellence is part of the FDA’s work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings. The Digital Health Center of Excellence will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff.”"

Read the full press release: FDA Launches the Digital Health Center of Excellence - FDA.gov

Go to the: Digital Health Center of Excellence - FDA.gov

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UDI System: The Final Regulation - Free FDA CDRH Video

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FDA | CDRH Learn | Unique Device Identification (UDI) System

"Unique Device Identification (UDI) System"

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2013 Plan For FDA CDRH Guidance Documents

The CDRH is considering developing a variety of guidance documents in fiscal year 2013. Specific topics and status as final and draft guidance document, are provided in the two lists:

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Prioritized medical device guidance documents that the Agency intends to publish in FY 2013 ("A-list")

Final Guidance Topics

• Refuse to Accept (RTA) Policy for 510(k) Submissions
• Acceptance and Filing Review for Premarket Approval Applications
• Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
• In Vitro Companion Diagnostic Devices
• Design Considerations for Pivotal Clinical Investigations for Medical Devices
• De Novo Classification Process (Evaluation of Automatic Class III Designation)
• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
• CDRH Appeals Processes
• Medical Device Classification Product Codes
• The Pre-Submission Program and Meetings with FDA Staff
• Mobile Medical Applications
• eCopy
• Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents

Draft Guidance Topics

• Distinguishing and Reporting Medical Device Recalls from Product Enhancements
• Types of Communication During the Review of Medical Device Submissions
• FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
• eCopy
• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

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Device guidance documents that the Agency intends to publish, as the Agency’s guidance-development resources permit each in FY 2013 ("B-list")

Final Guidance Topics

• Finalizing existing draft guidance documents.

Draft Guidance Topics

• Benefit-Risk Determinations in Premarket Notifications (510(k)s)
• Direct to Consumer (DTC) Genetic Testing: IVDs
• Transfer of Ownership of a Premarket Notification (510(k)) - Questions and Answers
• Custom Devices

Reference:  FDA CDRH Fiscal Year 2013 (FY 2013) Proposed Guidance Development

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