CDRH List of Planned Guidance Documents

FDA’s Center for Devices and Radiological Health (CDRH) published a list of guidance documents it intendeds to develop in Fiscal Year 2012 (FY12). Each year CDRH publishes a list and invites comments including draft language on the proposed topics and/or suggestions for new or different guidance documents. Submit electronic comments to at docket FDA-2007-N-0270.

The list includes:

510(k) Issues

  • 510(k) Modifications
  • 510(k) Paradigm (510(k) Program Guidance)

Medical Device Classification

  • Medical Device Classification Product Codes

Medical Device Reporting

  • Distinguishing and Reporting Medical Device Recalls from Product Enhancements
  • Medical Device Reporting
  • Electronic Medical Device Reporting


  • Appropriate Use of Consensus Standards in Premarket Submissions
  • Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program

Laboratory Developed Tests

  • Framework for Regulatory Oversight of Laboratory Developed Tests
  • FDA Notification and Medical Device Reporting for Laboratory Developed Tests
  • Quality System Requirements Guide for Laboratory Developed Tests

The full list of proposed guidance documents is at