Tuesday, December 4, 2012

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 Specific topics and status as final and draft guidance document, are provided in the two lists:


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Draft Guidance Topics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

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  • Finalizing existing draft guidance documents.

Draft Guidance Topics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


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