In an effort to help get safe and effective medical devices to market more quickly, the FDA publishes a list of proposed guidance documents each year. Here is FDA’s prioritized list of things you can expect to see in 2014:


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Draft Guidance Topics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)



Final Guidance Topics
  • Finalizing existing draft guidance documents.
Draft Guidance Topics
  • Medical Device Decision Support Software
  • Medical Device Accessories
  • General Wellness Products
  • Transfer of Ownership of a Premarket Notification (510(k)) - Questions and Answers
  • Direct to Consumer (DTC) Genetic Testing: IVDs
  • Device Interoperability


The focus this year is on finalizing some of the draft guidance documents published in recent years. But, I’m really looking forward to some of the new guidance documents in the “B-list”, so I sure hope the FDA gets to them! In particular, I’m very interested in getting clarifications on “Medical Device Accessories”. Also on the “B-list” is a new guidance for “Direct to Consumer Genetic Testing” which will likely reflect FDA’s recent sentiments in the Warning Letter issued to genetic test maker 23andMe. The FDA has already knocked one of these to-do items off the list, as they issued the draft guidance for Custom Device Exemption on January 14.


Sign up for ‘CDRH New’ updates to be e-mailed immediately when new guidances are released. Happy reading!


- Sherri

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