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 http://www.regulations.gov 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
Standards
- 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109196.htm