FDA Publishes List of Priorities for 2014

FDA’s Center for Device and Radiological Health issued a list of guidance documents that it intends to publish in FY2014. The topics that might be of interest to orthopaedic device companies include the following.

FDA’s Center for Device and Radiological Health (CDRH) issued a list of guidance documents that it intends to publish in FY2014. Each year, CDRH posts an A-list and a B-list of priorities. The topics that might be of interest to orthopaedic device companies include:

A-List
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
  • 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Draft Guidance Topics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

For FDA’s B-list of priorities as well as the guidance documents that were withdrawn, click here.