CDRH Wants to Publish at Least 12 Final Guidance Documents in 2016

By MedTech Intelligence Staff

From human factors to laboratory developed tests to medical device reporting, CDRH has ambitious plans for 2016.

CDRH has released its plans for publishing guidance documents in 2016, which includes an A-list, B-list, and final guidance documents from previous years that are subject to a “focused retrospective review”.  The center has prefaced this list with the acknowledgement that the publication of both final and draft guidance documents may be constrained by agency resources and other issues that arise during the year.

A-List Final Guidance

  • General Wellness Products
  • Medical Device Accessories
  • Benefit-Risk Factors to Consider when Reviewing IDE Submissions
  • UDI Direct Marking
  • Adaptive Design for Medical Device Clinical Studies
  • Incorporating Patient Preferences into Medical Devices Premarket Approvals, Humanitarian Device Exemptions, and De Novo Classifications
  • Applying Human Factors & Usability Engineering to Optimize Medical Device Design
  • Policy for Regulatory Oversight of Laboratory Developed Tests (LDTs)
  • Submission and Review of Sterility Information for Devices Labeled as Sterile
  • Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing (Biocompatibility)
  • Postmarket Surveillance Studies Under Section 522 of the Food, Drug, and Cosmetic Act
  • Medical Device Reporting (MDR) for Manufacturers

A-List Draft Guidance

  • Medical Device Decision Support Software
  • Use of Symbols in Labeling
  • 510(k) Modifications
  • Software Modifications
  • 510(k) Third Party Review Program
  • Companion Diagnostics Co-Development
  • Use of Real-World Observational Patient Data to Support Decision Making for Medical Devices
  • UDI Convenience Kit
  • Public Notification of Emerging Postmarket Medical Device Signals

The documents that made the B-list, which include medical device interoperability and defining the unique device identifier, are available on FDA’s website.

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