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Draft Guidance Topics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For FDA’s B-list of priorities as well as the guidance documents that were withdrawn, click here.
