DDR / BECS Accessories Medical Device Data Systems / Donor Management Information Systems / Information Data Management Inc. / Advanced Medical Systems / ISO IEC 12207 Systems / Computer Sciences Corporation / Blood Establishment Computer Software / /
Country
United States / /
Event
Product Issues / /
Facility
General Hospital / /
IndustryTerm
software performance / establishment software programs / software device / blood products / medical device software / predicate device / technology advances / manufacturing practices / preamendments device / software devices / Wireless capability / designed software / manufacturing practice / electrical hardware / cleared devices / classification regulations classifying devices / wireless hardware / connected medical devices / energy / wireless handheld device / marketed device / subject device / energy source / postamendments device / physical communications / device software-software life cycle processes / to all medical devices / transfusion management systems / stand-alone software applications / donor systems / manufacturing / to this device / defective software / preamendments devices / /
MedicalCondition
PDA / HIV / disease / certain infectious diseases / /
Organization
FDA's Center for Biologics Evaluation and Research / Food and Drug Administration / House Subcommittee / U.S. Securities and Exchange Commission / Blood Products Advisory Committee / FDA / General Hospital / American National Red Cross / Draft Policy / /
Position
personal digital assistant / General / /
Product
software / /
Technology
smart phone / personal digital assistant / laptop computer / operating system / PDA / /
FDA Executive Summary Classification of Blood Establishment Computer Software (BECS) and BECS Accessories Prepared for the December 3, 2014