Just adding some links to support the above comment - HITEC was part of the "American Recovery and Reinvestment Act of 2009" [1] following Hurricane Sandy. Add

Just adding some links to support the above comment - HITEC was part of the "American Recovery and Reinvestment Act of 2009" [1] following Hurricane Sandy. Additional clarifications for internet-enabled devices was released by the FDA in early 2015. [2] [1] https://www.gpo.gov/fdsys/pkg/PLAW-111publ5/html/PLAW-111publ5.htm https://www.gpo.gov/fdsys/pkg/PLAW-111publ5/html/PLAW-111pub... [2] http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf http://www.fda.gov/downloads/MedicalDevices/DeviceRegulation...