With the increasing prevalence of digital health products and technology, the US Food and Drug Administration (US FDA) has launched several new pieces of guidance in an update of its digital health policies.

The policy objectives are to encourage the development of healthcare tools and innovation, to establish regulations that better align with the iterative and swiftly evolving nature of digital health products, and to enhance access to information for both healthcare providers and patients to promote informed decision making.

There are three primary pieces of guidance that have been released in 2017:

  • Software as a Medical Device: Clinical Evaluation (Final Guidance);
  • Clinical and Patient Decision Support Software (Draft Guidance); and
  • Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (Draft Guidance).

These may have implications on the healthcare and medtech industries in Singapore.

Software as a Medical Device: Clinical Evaluation

The US FDA issued a final guidance on "Software as a Medical Device: Clinical Evaluation", which establishes principles for the evaluation of the safety, performance, and effectiveness of Software as a Medical Device (SaMD). A SaMD is a software which utilizes an algorithm that operates on data input to produce an output intended for medical purposes.

The underlying approach recommended by the US FDA in this guidance is an assessment of the SaMD's overall risk, namely by considering two factors:

(i)The state of the healthcare situation or condition; and
(ii) The medical purpose and significance of the information provided by SaMD to the healthcare decision.

The guidance also borrows vocabulary from, and provides practical application of, the risk framework suggested in the US FDA's 2014 guidance, "Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations". The framework uses four different levels of risk (Levels I, II, III and IV) based on the possible impact to the patient or to public health, with the highest risk level (Level IV) arising from situations where the accuracy of the information provided by the SaMD is vital to avoid death, long-term disability or a serious deterioration of health.

An example of assessing the four levels of risk based on the two factors is provided by the US FDA in the guidance:


The guidance also recommends a series of association and validation checks, and emphasizes independent review of a SaMD's clinical evaluation, with respect to clinical and analytical medical literature. These recommendations ameliorate the risks of using SaMD - for example, the risk of inaccurate or incorrect output of the SaMD - while maintaining the benefits of efficiency and better clinical management.

Details of the guidance can be found here.

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