FDA publishes final guidance on software as a medical device

Pharma IQ News

The final guidance from the FDA confirms quality management systems continue to be critical to the production of Software as a Medical Device (SaaMDs). 

health app

Digital health contributes a numerous financial and accessibility benefits to today’s society. For example, one smart watch app managed to triple enrollment rates for a clinical study. 

What is Software as a Medical Device (SaaMD)? A standalone computer program intended for medical purposes - so it isn’t attached to any medical device hardware. Smartphone and computer apps can be deemed as SaaMDs.  Medical purposes comprise of treatment, diagnosis and/or clinical management.

Developers of apps need to be aware of the regulations attached to SaaMDs which protect user safety – in terms of their data, health and finances.


Back in 2015, in an interview with Pharma IQ Rob Higgins Senior Regulatory Specialist for Devices at the MHRA mentioned: “…The main problem we’ve got at the moment is manufacturers or designers of apps are putting apps on the market [and are] not aware that there is regulation covering those products.” The authority underwent a huge drive to eliminate this issue.

In October of last year, a group of researchers based in Australia created an interactive guide to raise further awareness for this issue and support manufacturers to produce compliant apps.

A badly validated app in terms of compliance could incur significant harm.

For example, if improper validation is conducted for an app that calculates medicine dose, if the app gives the incorrect dose to a patient, there could be fatal consequences.

Read more: A health app developer’s guide to law and policy: a multi-sector policy analysis

New FDA Guidance 

Last December, the FDA published a selection of guidance documents to support the development of digital health tools and Software as a Medical Device.

The FDA Clinical and Patient Decision Support Software draft guidance looked to clarify what types of Clinical Decision Software the body does not categorise as a medical device. The developers of these devices do not have to adhere to FDA regulation. 

In his statement, FDA Commissioner Scott Gottlieb, M.D said that the final guidance document for SaaMDs “…provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product. The agency's adoption of these principles provides us with an initial framework when further developing our own specific regulatory approaches and expectations for regulatory oversight, and is another important piece in our overarching policy framework for digital health.”


The creation of a SaaMD hinges on development lifecycle activities which are supported by automated software tools. With this in mind, a Quality Management System (QMS) is vital to control and maximise quality in a SaaMD. A QMS allows for activities to be scaled in accordance with the type of medical device, the risk associated with the product and other factors. 

The original guidance on QMS systems from the International medical device regulators forum (IMDRF) remains valid in light of the FDA updates. The guidance document from the voluntary group of national medical device regulators from Australia, Brazil, Canada, China, Japan, Russia, Singapore, the United States and European countries states:

 “An effective QMS for SaMD should include the following principles:

· An organizational structure that provides leadership, accountability, and governance with adequate resources to assure the safety, effectiveness, and performance of SaMD,

 · A set of SaMD lifecycle support processes that are scalable for the size of the organization and are applied consistently across all realization and use processes and

· A set of realization and use processes that are scalable for the type of SaMD2 and the size of the organization; and that takes into account important elements required for assuring the safety, effectiveness, and performance of SaMD.”

New Guidance on QMS

The recent guidance from the FDA did build on QMS principles for the design and development of SaaMDs.

The QMS should encompass a continuous process on the clinical evaluation of the SaaMD.

In meeting requirements for the analytical validation of a SaMD, manufacturers need to evidence it produces clinically relevant outputs. Proof should illustrate the SaMD has been piloted with the target demographic.

Intended users should be able to “achieve clinically meaningful outcomes through predictable and reliable use.”

The quality management system’s verification and validation efforts can be used to support sourcing the evidence for clinical significance.

Read more: Software for Medical Devices Cyber Security