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Original Message:
Sent: 13-Mar-2024 14:37
From: Naveen Agarwal
Subject: "Indication for Use" and "Intended Purpose"
@Kevin Randall this is the most robust and on-point explanation of these concepts I have ever seen.
Thank you!
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Naveen Agarwal, Ph.D.
Problem Solver | Knowledge Sharer.
Let's Talk Risk!
@https://naveenagarwalphd.substack.com/
Original Message:
Sent: 12-Mar-2024 16:11
From: Kevin Randall
Subject: "Indication for Use" and "Intended Purpose"
For some of the most substantial aspects of regulatory practice by regulators, there are profound differences between "Intended Use" (a.k.a. "Intended Purpose") vs. "Indications for Use". Thus, it is imperative that regulated parties establish and practice a fluent understanding of the differences. Admittedly, this can be a challenge because technically, the Indications for Use are encompassed within the Intended Use/Purpose. Thus, their distinction can be nebulous if not handled carefully. Moreover, there is little or no local deliberate harmonization of these terms specifically aimed at harmonization with other jurisdictions. However, the GHTF/IMDRF has documented a harmonization baseline for this which is of valuable because, for example, the U.S. FDA, Europe's Union MDR, and others, are partial to the GHTF/IMDRF approach. Below I give some further background and explanation of why these distinctions are in fact germane and important for our day-to-day regulatory operations.
The U.S. FDA for example for the medical device sector defines 'Intended Use' plainly and simply as the objective intent of the persons legally responsible for the labeling of an article (or their representatives). In a previous Forum post I summarized this as the general purpose of the device or its function as shown by the labeling (or other indications of the sponsor's intent). Generality, rather than specificity, is a core essence of this definition. Europe's medical device regulation 2017/745 defines it similarly (yet calling it 'Intended Purpose' in some 80 instances while calling it 'Intended Use' in some 17 instances but meaning the same thing in my interpretation) as the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation. The IMDRF defines it for harmonization purposes as the objective intent regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer. Similarly, ISO 14971, IEC 62366, and indirectly, ISO 20417, define it in part as the use for which a product is intended according to the specifications, instructions and information provided by the manufacturer. I find these definitions to align nicely with one another therefore making a good foundation for a harmonized definition within a regulated entity's quality management system and regulatory processes.
Regarding the different term "Indications for Use", the U.S. FDA for the medical device sector officially defines this distinctly as a description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended. Thus, once we expand on general intent and start to prescribe a specific disease state or patient population or subpopulation (e.g., home use, pediatric use, etc.), then that generally establishes certain specific Indications for Use rather than (yet within) the overall Intended Use. Europe's Union MDR also repeatedly distinguishes the indications from the Intended Purpose/Use and, by my interpretation, is not inconsistent with FDA's approach where again, the indications are subparts of the overall Intended Purpose (Use). Similarly, the IMDRF defines "Indications for Use" as a general description of the disease or condition the medical device or IVD medical device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the medical device or IVD medical device is intended. I also get additional insight on the meaning of "Indications for Use" by reverse-engineering the often officially defined term "Contraindication". Oddly, ISO 20417 doesn't appear to define "Indications for Use". Finally, remember also that sometimes, specific Indications for Use are neither stated, implied, nor necessary. In such instances, then the Indications for Use and the Intended Use are one and the same.
The Health Canada medical device jurisdiction can be tricky as I cannot find in either the Canadian Food and Drugs Act nor the Canadian Medical Devices Regulations an official definition for 'Intended Use' nor 'Indications for Use'. Yet a hybridized descriptive concept is present and asserted as, "the medical conditions, purposes and uses for which the device is manufactured, sold or represented." In addition, Health Canada's medical device labeling guidance echoes and expands upon the IMDRF definition for "Indications for Use" defined as, "...a general description of the disease(s) or condition(s) the device will diagnose, treat, prevent or mitigate, including where applicable a description of the patient population for which the device is intended. The indications include all the labelled uses of the device, for example the condition(s) or disease(s) to be prevented, mitigated, treated or diagnosed, part of the body or type of tissue applied to or interacted with, frequency of use, physiological purpose and patient population...", yet contains no definition of Intended Use.
So why is the distinction between "Intended Use" and "Indications for Use" important? Much can be said about that. I'll simply say that each has a specific impact on the premarket and post-market regulatory process and submissions. Thus, they must be appropriately handled in order to assure success. For example, regarding the U.S. medical device jurisdiction, the Intended Use is linked to, and intrinsically governs/establishes the applicable classification regulation (e.g., 21 CFR 8XX.XXXX) that must be stated in a 510(k). The same is true regarding Europe's, Canada's, and others' classification schemes. Intended Use also dictates the differentiation between a medical device, drug, combination product, or non-medical product. In contrast, the Indication(s) for Use is/are linked more so to, for example, the corresponding FDA Product Code (if at all) which must also to be stated in the 510(k), but in any event, distinctly stated by way of the FDA Form 3881 and in the labeling. For any jurisdiction, the Indications for Use will have considerable impact on the required nature and extent of supporting developmental data (bench, preclinical, clinical, etc.) Moreover, post-market change assessments are significantly impacted by these distinctions. For example, a change in Intended Use is generally an automatic trigger for a new classification assessment and regulatory authorization, whereas a new Indication for Use may or may not require a new regulatory authorization.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 12-Mar-2024 03:34
From: Richard Vincins
Subject: "Indication for Use" and "Intended Purpose"
Bonjour Fabienne,
The topic of Intended Use, Indications for Use, and Intended Purpose is an on-going topic of discussion today and will continue probably far into the future. There are a few posts over the years on this forum concerning this topic as well. The US FDA has defined this quite a few years ago https://www.fda.gov/regulatory-information/search-fda-guidance-documents/generalspecific-intended-use-guidance-industry and recently in 2021 CDER (regulated drugs) also updated their definition. Though even the FDA uses the terms interchangeably from time to time, but they do focus on Specific Intended Use or Indications for Use.
The EU MDR does state and define intended purpose though uses this interchangeably throughout with intended use. Also, a couple MDCG guidance documents confuse it even more because these often use those terms interchangeably. When I have been writing documents in the EU, I recommend clearly stating the Intended Purpose, Intended Use, and Indications for Use so it is clear. For some devices, the intended use and indications for use are the same or can be the same. In the US, always default to the indications for use first as this is what is needed in the regulatory submission.
These are my own definitions mostly based on FDA's usage, FDA guidance, and content contained in regulatory submission.
Intended Purpose: This is the most broad sense of the medical device for how it is used, why it is used, who is using it, where it is used, circumstances of use, when it should not be used, etc. An example is a heating pad can be used to relieve sore muscles in different parts of the body used by a lay-person at home or other environment. There are no circumstances where the heating pad can not be used and only used for person age 12 and older. (FDA uses this term more, but they also have terms such as Mode of Action or Conditions of Use which apply here as well.)
Intended Use: This is a broad sense of the diagnostic, monitoring, or treatment for the medical device. The example is a heating pad can be used to relieve sore muscles.
Indications for Use: This is a specific statement for the disease condition, anatomy, or conditions for the medical device. The example is a heating pad can be used to relieve sore muscles and increase blood circulation in the upper back, shoulders, and neck for individuals above the age of 12.
Again, those are my view on the intended purpose and intended use with quite different variations depending on the regulatory agency and the medical device being viewed. As said, I state all three of these (as needed) clearly defined in regulatory documents to make clear which is being used.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
Original Message:
Sent: 11-Mar-2024 07:01
From: Fabienne Weiss
Subject: "Indication for Use" and "Intended Purpose"
Dear RAPS community
I have read that the "indication for use" and the "intended purpose" are actually the same. The US market uses the term "indication for use" and the EU MDR uses the term "intended purpose". Is this correct or are there small differences between these two terms?
Thank you for your answer.
Best regards
Fabienne
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Fabienne Weiss
Scientific Assistant
Berner Fachhochschule
Biel
Switzerland
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