Table 2.

“If my software product is regulated by the FDA, how do I bring it to market?'

Go-to-market strategy	Risk classification options	Is the product making a“device” claim (e.g., what's the intended use)?	Can the manufacturer bring the product straight to market?	Does the manufacturer need to“register and list”?	Does the FDA review the product?	Is the manufacturer required to submit postmarket information (e.g., medical device reporting)?	Does the manufacturer need to pass a pre-cert excellence appraisal?	Is this pathway “live”?	Related documents
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
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
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
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
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