其他| 1. | Food and Drug Administration。Is the Product a Medical Device?，https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm。   |
| 2. | (2012)。Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device'，Global Harmonization Task Force。(GHTF/SG1/N071:2012)。 |
| 3. | Software as a Medical Device Working Group。Software as a Medical Device (SaMD): Clinical Evaluation，https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm524904.pdf。 |