CDRH lists proposed documents for FY11

Each year CDRH publishes a list of proposed new documents for the upcoming fiscal year. CDRH published the FY11 list on Oct. 6, 2010.

Some the proposed documents are in the list below.

Guidance on Postmarket and Compliance Issues
Medical Device Reporting for Manufacturers
“510k Actions”-FDA and Industry Actions on Premarket Notification Submissions
Research Use Only
Distinguishing Medical Device Enhancements from Product Recalls and Corrections

Electronic Medical Device Reporting

Global Harmonization or Standards Related Guidances
Global Harmonization Task Force: Quality Management System; Process Validation
Global Harmonization Task Force: Post Market Surveillance; National Competent Authority Report Exchange Criteria and Report Form
Application of IEC 60601-1 Third Edition
Medical Device ISO 13485

Cross-Cutting, Process, and Other Guidances
Radio-Frequency Wireless Technology in Medical Devices
Quality Systems for Laboratory Developed Tests
Medical Device Home Use

You may view the complete list at