The article provides a general overview of the regulatory requirements, and also briefly describes the key concepts.
Table of Contents
The United States Food and Drug Administration has released a guidance document about Off-The-Shelf (OTS) software used in medical devices.
This document explains the regulatory requirements within the current legal framework and provides additional clarifications for medical device manufacturers and related parties to ensure compliance.
It’s essential to note that this guidance’s provisions are non-binding and don’t create new rules or obligations.
The FDA allows for alternative approaches if they align with existing legislation and have prior approval from the authority.
Regulatory Background
Off-the-Shelf (OTS) software is commonly integrated into medical devices, aligning with the growing use of general-purpose computer hardware in healthcare.
It allows medical device manufacturers to focus on device-specific application software rather than creating the software platform, leading to more efficient development.
However, the FDA notes that OTS software designed for general computing may not always be suitable for specialized medical device applications.
Manufacturers relinquish control over the software’s lifecycle while remaining responsible for ensuring the medical device’s safety and effectiveness for its intended use.
Outline
This guidance outlines the documentation sponsors should include in premarket submissions for marketing approval, streamlining the FDA’s evaluation process by clarifying essential information during software development, verification, and validation.
To support innovative medical device development, including novel software solutions, the FDA adopts a least burdensome approach, emphasizing critical aspects for proper device performance and patient safety.
Recognizing rapid technological advancements, the FDA retains the right to update this guidance as new information emerges.
Multiple revisions have already been made, and ongoing development is planned.
Scope
The guidance aims to offer further insights regarding the documentation the authority requires from applicants in premarket submissions involving OTS software and products utilizing such solutions.
OTS software refers to a readily available software component used by medical device manufacturers, over which they don’t have complete software lifecycle control, such as operating systems or printer/display libraries.
In essence, this term describes software components created by third parties and later used by medical device manufacturers to fulfill specific functions.
For the purposes of this document, “premarket submission” encompasses various types of submissions under different legal frameworks, including but not limited to:
Also, for devices with multiple functions and software functions labeled as “other functions,” manufacturers should consult the guidance document “Multiple Function Device Product: Policy and Considerations.“
Documentation: Key Points
To aid those marketing medical devices with OTS software, the document details required submission documentation.
This ensures the authority assesses product safety and effectiveness effectively.
The documentation specifics vary, determined case by case, considering factors like device risk. Regulatory scrutiny levels are established via a risk-based approach.
The authority considers these factors to determine whether the Documentation Level applied should be Basic or Enhanced.
The Documentation Level’s purpose, is to define minimal data for premarket submissions with device software functions.
It mirrors the device, considering software function risks in the intended context.
In summary, the FDA guidance provides a concise overview of OTS software regulatory requirements in medical devices, emphasizing key concepts and essential compliance factors.
Sources:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices
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