The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has released its fiscal year 2014 plans for guidance development.

Prioritized Areas Of Focus Include the following Final and Draft Topics:

Final Guidance Topics

  • Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A
  • Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
  • Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act
  • De Novo Classification Process (Evaluation of Automatic Class III Designation)
  • The Pre-Submission Program and Meetings with FDA Staff
  • The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
  • Types of Communication During the Review of Medical Device Submissions
  • Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents
  • Applying Human Factors and Usability Engineering to Optimize Medical Device Design
  • In Vitro Companion Diagnostic Devices
  • Global Unique Device Identification Database
  • Design Considerations for Pivotal Clinical Investigations for Medical Devices

Draft Guidance Topics

  • Benefit-Risk Determinations in Premarket Notifications (510(k)s)
  • Appropriate Use of Voluntary Consensus Standards in Premarket Submissions
  • Custom Devices
  • Hearing Aids and Personal Sound Amplification Products (PSAPs)
For more information and to provide comments on the proposed guidance documents planning visit the CDRH website: HERE

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