Software Validation
FDA guidance for medical device software can be found in the document titled General Principles of Software Validation; Final Guidance for Industry and FDA Staff. All software—from machine-tool embedded software, to materials-planning software, to simple spreadsheets, to the software controlling a medical device—is subject to these regulations. In cases where the software is developed by someone other than the device manufacturer (e.g., off-the-shelf software), the device manufacturer is responsible for compliance with FDA regulations, not the software developer. This guidance outlines general validation principles that the FDA considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices.
The document titled Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices provides the industry with information regarding the FDA-recommended documentation to be included with premarket submissions for software devices, including stand-alone software applications and hardware-based devices that incorporate software.
In February 2015, the FDA issued the document titled Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff. This document is intended to provide clarity and predictability for manufacturers of mobile medical apps. As per the document: “Consistent with the FDA’s existing oversight approach that considers functionality rather than platform, the FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended. This subset of mobile apps the FDA refers to as mobile medical apps.”[1]
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