FDA Device Software Regulation

April 21, 2016
April 22, 2016
225 William F. McClellan Highway
Boston, MA 02128
US
Phone:1-800-447-9407

Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles. Software may be a standalone device, control a device's performance, make calculations, identify treatment options or begin to play a more active role in making clinical decisions regarding patient management and treatment. FDA's risk classification will gradually clarify how it intends to manage the health risks. Software use has become increasingly complicated with the expansion of software applications, for example: cybersecurity, interoperability, mobile medical "apps," home use and remote use. Another growing concern is the public's use of software programs to manage their health issues rather than go to a healthcare professional.

More Events
Upcoming event
SCOPE
August 23, 2020August 25, 2020
Upcoming event
CSCMP Edge
September 20, 2020September 23, 2020
Upcoming event
Cold Chain Conference & Expo
September 28, 2020September 30, 2020
Upcoming event
Grocery Delivery Connect
October 7, 2020October 9, 2020
Upcoming event
National Frozen & Refrigerated Foods Convention
October 17, 2020October 20, 2020
Upcoming event
IFDA - Distribution Solutions Conference
October 25, 2020October 28, 2020
Upcoming event
CEBA Conference & Expo
November 10, 2020November 12, 2020
Upcoming event
TPM 2021
February 28, 2021March 3, 2021
Upcoming event
ProMat
April 12, 2021April 15, 2021