The product is NOT a device, and isnot regulatedby the FDA |
N/A, not a device |
No |
Yes |
No |
No |
No |
No |
Yes |
Mobile health apps interactive tool(HHS, ONC, OCR, and FDA): https://www.ftc.gov/tips-advice/business-center/guidance/mobile-health-apps-interactive-tool
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The product IS a device, but the FDA will exercise“enforcement discretion ”and will not regulate it |
Class I or II |
Yes |
Yes |
No |
No |
No |
No |
Yes |
Examples of mobile apps for which the FDA will exercise enforcement discretion:
https://www.fda.gov/medicaldevices/digitalhealth/mobilemedicalapplications/ucm368744.htm
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|
The product IS a device and isexemptfrom review by the FDA |
Class I or II |
Yes |
Yes |
Yes |
No |
Yes |
No |
Yes |
Class I/II exemptions:
https://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm051549.htm
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The product IS a device and will be reviewed under theFDA Pre-Cert program
|
Class I, II, or III (or will fall under newly proposed IMDRF risk determination) |
Yes |
No |
Yes |
Yes |
Yes |
Yes |
No (In pilot) |
Digital health software precertification (Pre-Cert) program:
https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/default.htm
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The product IS a device and will be reviewed under one of thetraditional CDRH pathways(e.g., 510k, de novo or PMA) |
Class I, II, or III |
Yes |
No |
Yes |
Yes |
Yes |
No |
Yes |
FDA Division of Industry and Consumer Education (DICE):
https://www.fda.gov/medicaldevices/deviceregulationandguidance/contact-divisionofindustryandconsumereducation/default.htm
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