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Understanding the calculator software exclusion

Guidance on when software that makes calculations may be excluded from our regulatory requirements.

Published

Purpose

If you are a software developer, manufacturer or product sponsor it is your responsibility to check whether your software or digital product is excluded from our regulation before you release it for supply in Australia.

There are currently 15 excluded software categories listed in Schedule 1 of the Therapeutic Goods (Excluded Goods) Determination 2018 (the Determination).

This guidance relates to software that makes calculations, which may be excluded from our regulation under item 14L of the Determination.

Legislation

Introduction

We regulate all software-based products in Australia that meet the definition of a medical device unless they meet one of 15 excluded software categories.

If your product meets the definition of a medical device in Section 41BD of the Therapeutic Goods Act 1989 it must be included on the Australian Register of Therapeutic Goods (ARTG) before it can be marketed or supplied in Australia unless a valid exemption is in place.

However, some software products intended for population-based analytics could be excluded from our regulation under item 14N of the Determination.

Note: Software with multiple functions

Every feature of software with multiple functionalities must meet the exclusion criteria to qualify for an excluded software category.

About this exclusion category

Exclusion 14L applies to software that makes calculations using authoritative sources such as published clinical standards or displays the calculation steps or logic so that the user can validate the result.

Extract: Item 14L

Software that is a calculator and

  1. either:
    1. uses relevant published clinical standards or authoritative sources to make calculations; or
    2. displays calculations and outputs in a manner that may be validated by the user; and
  2. is not intended by its manufacturer to control the administration of a calculated dosage.

This exclusion does not apply to software that are not numerical calculators. For example, tools that are rules-based, based on decision trees, or scoring tools that assign number values to text-based questions to produce a weighted score.

If your software has any functionality other than numerical calculations, you must consider if those functions would be captured as a medical device.

Check if your software is excluded

This exclusion is based on 4 questions.

If you answer YES to the following three questions, the exclusion may apply:

  1. Is your software a calculator?
  2. Does your software use relevant published clinical standards or authoritative sources to make calculations?
  3. Does your software display the calculations and outputs in a manner that may be validated by the user?

If you answer YES to the following question, your software is not excluded:

  1. Does your software control the administration of a calculated dosage?

Flowchart for determining if software is excluded by 14L

Flowchart for determining if software is excluded by 14L

A decision flowchart that explains when certain software is excluded or not excluded from our regulation based on its function in relation to dosage calculation, display, and clinical standards.

The flowchart is read from top to bottom and left to right, progressing through a series of yes‑or‑no questions. Each path ends in either "Excluded" or "Not excluded."

The process begins with the following question: "Is your software a numerical calculator that controls the administration of a calculated dosage?"

If the answer is YES, the software is not excluded, and the decision process ends.

If the answer is NO, the flow continues to the next question.

The second question is: "Does it display the calculations and outputs in a manner that may be validated by the user?"

If the answer is YES, the software is excluded, and the decision process ends.

If the answer is NO, the flow continues to the next question.

The third question is: "Does it use relevant published clinical standards?"

If the answer is YES, the software is excluded.

If the answer is NO, the software is not excluded.

Examples

Excluded software

Example: Calculator for volume of fluids

Software that calculates the volume of fluids needed for a burn patient using the Parkland formula.

It displays the mathematical formula and results for each of the calculation steps.

This calculator would be excluded from our regulation because the software:

  • uses the Parkland formula (a relevant published clinical standard formula)
  • displays the formula and calculation logic so users can see if the results are correct or as expected.

Not excluded

Example: Chemotherapy medication calculator

Software that is part of an intravenous device administering chemotherapy medication that calculates the volume and frequency of each dose.

This software would not be excluded from our regulation because it also controls the administration of a calculated dosage and is therefore a medical device.

Glossary

TermDefinition
Calculator

Your software includes a function that acts as a digital numerical calculator, it implements mathematical formulas.

It could be the digitised version of a pain medication dose calculator, or a calculator on a smartphone that is linked to a health-related app or system.

This exclusion does not apply to software that are not numerical calculators. For example, tools that are rules-based or based on decision trees, or scoring tools that assign number values to text-based questions to produce a weighted score.

If your software has any functionality other than numerical calculations, you must consider if those functions would be captured as a medical device.

Relevant published clinical standards or authoritative sources

Your software's calculator function follows a relevant published clinical standard formula.

This means it is either in common usage, like the Parkland formula, or may be subject to another form of regulation and/or certification, like a weight-based dosage calculation for a medicine that follows a formula in the product information (PI) published for that medicine.

Display the calculations and outputs in a manner that may be validated by the user

If your software's calculator function displays or steps through the logic of the calculation, or the formula itself, for example patient weight x 100 mg for the user to see, then it is excluded.

If the calculation is sufficiently complex that it is not practical to present this logic, or that the intended user cannot easily understand the logic and the calculation is not based on a published clinical standard or authoritative source, the calculator will not be excluded.

Control the administration of a calculated dosage

Your software's calculator does more than provide information. It also schedules, determines, and/or delivers calculated doses of medicine to a patient.

The administration can be automatic, for example software that controls the dosage delivered by a medication pump, or manual (the software specifies what the user must do and when).

If the calculator specifies a dosage in this way, then it is not excluded.

Product types

Page history

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Published using selected content previously located in guidance titled 'Understanding if your software-based medical device is excluded from our regulation.'

Published using selected content previously located in guidance titled 'Understanding if your software-based medical device is excluded from our regulation.'