Just adding some links to support the above comment - HITEC was part of the &quot;American  Recovery and Reinvestment Act of 2009&quot; [1] following Hurricane Sandy. Additional clarifications  for internet-enabled devices was released by the FDA in early 2015. [2]<p>[1] <a href="https:&#x2F;&#x2F;www.gpo.gov&#x2F;fdsys&#x2F;pkg&#x2F;PLAW-111publ5&#x2F;html&#x2F;PLAW-111publ5.htm" rel="nofollow">https:&#x2F;&#x2F;www.gpo.gov&#x2F;fdsys&#x2F;pkg&#x2F;PLAW-111publ5&#x2F;html&#x2F;PLAW-111pub...</a><p>[2] <a href="http:&#x2F;&#x2F;www.fda.gov&#x2F;downloads&#x2F;MedicalDevices&#x2F;DeviceRegulationandGuidance&#x2F;GuidanceDocuments&#x2F;UCM263366.pdf" rel="nofollow">http:&#x2F;&#x2F;www.fda.gov&#x2F;downloads&#x2F;MedicalDevices&#x2F;DeviceRegulation...</a>