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 Specific topics and status as final and draft guidance document, are provided in the two lists: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Draft Guidance Topics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• Finalizing existing draft guidance documents.

Draft Guidance Topics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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