OBJECTIVES

With the recent emergence of software as a medical device (SaMD) regulators have developed initial frameworks to assess these new interventions. This is different from other digital health technologies as it requires regulatory approval, similar to that of new drug molecules. Due to the novelty of the area, strict definitions classifying a technology as a SaMD has yet to be finalized. This has led to ambiguity surrounding SaMD definitions and due to this, technologies have been assessed on a case by case basis using general outlined inclusion or exclusion criteria. Here we conducted a review of guidelines between Canada, USA, United Kingdom (UK), Germany, and Australia.

METHODS

Regulatory guidelines surrounding software as a medical device (SaMD) for the Food and Drug Administration (FDA), Health Canada (HC), Medicines and Healthcare products Regulatory Agency (MHRA), Das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Therapeutic Goods Administration (TGA) were reviewed.

RESULTS

All five agencies have outlined initial public guidance documents surrounding regulation of SaMD. Between the jurisdictions, details surrounding monitoring, diagnostic, and predictive software capabilities within software impacted SaMD classification. Health Canada and the FDA included similar language that classified devices as a SaMD relative to the UK, Germany, and Australia. Other noticeable differences include risk classifications. Risk categories are determined based on the level of criticality of the healthcare condition or state. The FDA/HC include 3 risk categorizations (Class I, II, II), MHRA/TGA listed four (Class I, IIa, IIb, III) and BfArM only allows two risk classes (Class I, IIa) to be reviewed. Although agencies have outlined the necessity for post market surveillance, no specific details have been provided. No details surrounding cross-country data sharing was outlined.

CONCLUSIONS

North America regulations are more closely related compared to the UK, Germany, and Australia. Further consultations between SaMD companies and regulators are needed to strengthen regulatory guidelines.