The FDA issued a draft guidance document on ‘Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety & Effectiveness in Design’ for Industry and FDA Staff as of June 22, 2011. A 90 day comment period is
Federal Register: Comprehensive List of FDA Guidance Doc’s
Federal Register Comprehensive List of FDA Guidance Documents; Notice http://ht.ly/2nKfg
FDA Guidance & Fed Reg – FY 2011 Med Dvc User Fee Rates
FDA Guidance Fiscal Year 2011 Medical Device User Fee Small Business Qualification & Certification http://ht.ly/2nHdQ & Federal Register Medical Device User Fee Rates Fiscal Year 2011 http://ht.ly/2nHgX