How to comment on FDA CDRH FY11 Draft Guidance Documents? http://ht.ly/2OiXg From the FDA CDRH webpage titled “Documents the CDRH is Considering for Development (FY11)” the following is the intoduction to the page: “This is the list of guidance documents
IEC 60601-1-11, 1st ed. published Std for Med Elec Equip & Systems used in Home Healthcare Environ
IEC 60601-1-11, 1st edition, just published Apr 28, 2010. This is the Medical electrical equipment collateral Standard for Medical electrical equipment & systems used in home healthcare environments.
Should Medical Apps Face Government Oversight?
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FDA Requires Manufacturers to Include Info on Pediatric Populations
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US Devicemakers Given Three Year Transition to IEC 60601-1
Devicemakers Given Three Years to Transition to New Standard From FDA News Devices & Diagnostic Letter March 29, 2010 Devicemakers may have to pay up to 40 percent more to test the safety and effectiveness of electronic devices now that
