FDA update October 3, 2011

Documents the Center for Devices and Radiological Health is considering for Development (FY12)

The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CDRH has already issued Level drafts that may be finalized following review of public comments.

This list of proposed guidance documents is not binding. CDRH is not required to issue every guidance document on the list and may issue guidance documents not on the list.

CDRH is considering developing following guidance documents in fiscal year 2012:

General Premarket Issues

  • Pre-Submission Interactions
  • Early Feasibility Studies
  • Decisions for Investigational Device Exemption Clinical Investigations
  • 510(k) Modifications
  • Design Considerations for Pivotal Clinical Investigations
  • Evaluation of Automatic Class III Designation (De Novo)
  • 510(k) Paradigm (510(k) Program Guidance)
  • Enforcement Policy for 510(k) for Certain IVDs and Radiology Devices
  • In Vitro Companion Diagnostic Devices

Post market and Compliance Guidance

  • Distinguishing and Reporting Medical Device Recalls from Product Enhancements
  • Medical Device Reporting
  • Annual Reports for Approved Premarket Approval Applications
  • Electronic Medical Device Reporting

Device Specific Guidances

  • Infusion Pump
  • Artificial Pancreas
  • Blood Lancets
  • Pediatric Information for X-ray Imaging 510(k)s
  • Live Case Presentations During Investigational Device Exemption Clinical Trials
  • Borrelia burgdorferi (Lyme Disease)
  • Medical Devices that Include Antimicrobial Agents
  • Low Glucose Suspend Devices
  • Computer-Assisted Detection Devices

Global Harmonization or Standards Related Guidances

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

Cross-Cutting, Process, and Other Guidances

  • CDRH Appeals Processes
  • Medical Device Classification Product Codes
  • Design Considerations for Devices Labeled for Home Use
  • 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
  • 513(g) Procedures
  • 513(g) User Fee
  • Radio Frequency Wireless Technology

PLEASE BE AWARE THAT THIS IS YOUR CHANCE TO MAKE YOUR THOUGHTS TO BE KNOWN: Written comments and suggestions may be submitted at any time for FDA   consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, refer to Docket No. FDA-2007-N-0270.

Or you can send your comments at info@mdiconsultants.com and REF: Documents considering for Development 2012.

For more information on this guidance you can go to the following link:http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109196.htm.