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Software as a Medical Device: Regulatory and Market Access Implications
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62. NMPA (September 2019). Key Review Points for Deep
Learning Decision Support Medical Devices Software.
63. Digital Health Software Precertification (Pre-Cert)
Program. FDA website. https://www.fda.gov/medical-
devices/digital-health/digital-health-software-
precertification-pre-cert-program. Accessed 16
February 2021.
Software as a Medical Device: Regulatory and Market Access Implications
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
62. NMPA (September 2019). Key Review Points for Deep
Learning Decision Support Medical Devices Software.
63. Digital Health Software Precertification (Pre-Cert)
Program. FDA website. https://www.fda.gov/medical-
devices/digital-health/digital-health-software-
precertification-pre-cert-program. Accessed 16
February 2021.