FDA guidelines for digital health tool development

medical device approval FDA digital health

Date: 28th September 2019

FDA momentum on policy regulations surrounding digital health technologies increases to keep up with the rapid advancements in the field.

New digital applications for disease diagnosis, treatment and management are a regular feature in our news at BioTechScope.  With a wide range of technologies now on offer, examples vary from smartphone applications detecting skin cancer, through to smart watches detecting atrial fibrillation to the, as yet unexplored, potential that the Genome Sensor™ may bring, and the digital healthcare industry is progressing at a remarkable speed.

A Plethora of digital health technologies are readily accessible

The drive behind the digital health industry is not only to provide hope and ease the suffering of millions of patients with debilitating diseases, but also to place the responsibility of our health into our own hands. The accessibility and wealth of information provided by real-time monitoring from devices such as wearables, allows us to make better and more informed decision on lifestyles and health choices.  In turn favouring our health and encouraging long term well-being.

FDA novel medical device approval

The FDA’s role here is to ensure timely access to high-quality, safe and effective digital health products

This week the FDA has released a suite of guidances to continue to encourage innovative approaches to the development of digital health tools.  These guidelines provide a regulatory framework that should balance the crucial role of technological advancement in digital healthcare along with evaluating the safety, risk and effectiveness of their use.

The first guidance issued relates to software that provides clinical decision support.  These types of software programs inform the physician’s clinical management of their patient, improving clinical decision making.  The FDA encourages developers to create, adapt and expand the functionalities of their software with the requirement that it doesn’t introduce unacceptable risk to the patient.

The second announcement clarifies the FDA’s interpretation of the types of software that are no longer considered medical devices. Those such as mobile apps that encourage healthy lifestyles but technologies posing low risk to patients and will not fall under FDA regulation.

Lack of policy and framework supporting digital health

The acceleration and adoption of digital health technologies is occurring at such a speed there has been growing concern that the regulatory landscape is falling behind. 

For many, the lack of policy guidance and framework surrounding digital healthcare is not compatible with patient safety.  It will therefore come with some relief that the FDA appears to be adapting its approach to deal with the rapid evolution of digital technologies.  It is hoped the incentive to drive the policies further will be sustained.  How the devices that fall outside the FDA remit are managed, if at all, will be a question for the future.

For further information on the FDA’s guidelines please read the press release.

Graphic data source: FDA