FDA announces guidance for regulating digital health software
In response to the increasing adoption of wellness apps and health technologies, the FDA has released new guidance for the development of digital health tools.
The FDA has released two draft guidance and one final guidance that highlights how the agency will approach digital health.
The FDA has been making steady progress into the regulation of digital health technologies and software. Earlier this year the agency issued an action plan which outlined its efforts into providing Americans with access to safe and effective digital health products.
Nine companies including Apple, Samsung and Fitbit have also been selected for the FDA’s Pre-Cert programme, which will help the agency determine if companies can submit less information than currently required before marketing a new digital health product.
The FDA’s first draft guidance clarifies how it will approach clinical decision support software (CDS). The software – which can help identify the best treatment plans for patients – is intended to clarify which types of CDS will no longer be classified as medical devices.
The second draft guidance is in response to the 21st Century Cures Act and addresses digital provisions already included in the act. The guidance details what types of software the FDA no longer considers medical devices.
In his statement, FDA commissioner Scott Gottlieb said: “We’re making clear that certain digital health technologies – such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle – generally fall outside the scope of the FDA’s regulation. Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the healthcare system.”
The new guidance includes general wellness and mobile medical applications and is intended to reflect the FDA’s new approach to how it classifies digital health products.
The third and only final guidance is in regard to Software as a Medical Device (SaMD). The guidance recognises the need “for analysing and assessing SaMD, based on the overall risk of the product”. The guidance was initially drafted in October 2016 and acts in fulfilment of advice set out in the “Software as a Medical Device: Clinical Evaluation report.
About the guidance, Gottlieb said: “In sum, these three important guidance documents being issued today will continue to expand our efforts to encourage innovation in the ever-changing field of digital health. Our aim is to provide more clarity on and innovative changes to our risk-based approach to digital health products so that innovators know where they stand relative to the FDA’s regulatory framework.”