Preparing a medical device for its intended market from the initial concept phase through to the final launch and commercial release can be very timely and depends on many factors. Labeling and classification of the medical device product are an essential part of the product development process. As part of the labeling phase, three terms are consistently used to help the end-user understand the purpose and proper use of the product itself. The words “Intended Use,” “Indications for Use,” and “Instructions for Use” are defined as the following.
“Intended Use” is defined as the general use statement of a medical product or “what is the use of the device?”1 It tells the user what the device is meant to do over the lifetime of the product. These generally are simple statements of no more than 2-3 sentences that outline the device’s tools specific use within a particular market.
“Indications for Use” can be defined as “what circumstances or what conditions you would use that particular product or device.”2. Examples of this include the conditions the device was designed to diagnose, treat, prevent, cure, or mitigate, as well as a description of the target patient population. This statement delves a bit deeper and offers additional insights into the purpose and manufacturing of the product.
Ultimately, it depends on the classification of your device and how your “intended use will affect your regulatory product classification.” 3 Planning out your regulatory strategy and applying relevant standards is always essential. It’s crucial to consider these things in the early stages of development. One statement may formalize one item, but once you start adding information, your devices’ classification, and therefore regulatory requirements, could change overall.
The next and most critical document or term outlined to be familiar with are of the “Instructions for Use” or IFU. The IFU is a detailed instruction booklet or sheet provided with each device, to fully ensure the proper use of the equipment is within the scope of which it was designed to diagnose, treat, or prevent. The IFU is a mandatory document required by the FDA and international regulatory bodies for any medical device submitted for approval under the 510(k), PMA, or global registration processes.
Regulatory departments, R&D engineers, and quality engineers work with clinicians to develop an IFU as part of the development process. If consultants are needed, resources or connections can be leveraged to support a customer’s needs as appropriate. Much of this information is already prepared based on the documents procured during the design and development process. The IFU outlines subjects, such as : product and device descriptions, user training, Knowledge and Skills needed to operate the device, Contraindications Warranties, and Troubleshooting tips and tricks. It acts much like an owner’s manual on a new tool you would use or a new technical device you would install at home.
It’s essential that device developers know that even before the development process begins, they need to start considering what materials they are going to use in their device and the impact on biocompatibility. Even though many materials have a long history of use in medical devices, developers may need to be able to provide new biocompatibility data on the completed device using these materials. FDA is unusually strict in requiring data on production-equivalent, finished devices. Depending on the device application and data available, the EU may accept biocompatibility from previous products using the same materials, or even material biocompatibility testing rather than complete device data.
The development of the IFU also takes into consideration the end-user, his/her situation, and how they would use the document itself. Additional aspects of folding, grasping, literacy, and basic symbology can become part of the document’s development.
Quality & Regulatory teams, alongside Engineers, work together to ensure that every device has the proper labeling, kitting, documentation, and packaging needs are in place and approved by the appropriate regulatory bodies before going to market.
Resources
- https://www.greenlight.guru/blog/intended-use-and-indications-of-use
- https://www.greenlight.guru/blog/intended-use-and-indications-of-use
- https://www.mddionline.com/why-you-must-know-difference-between-intended-use-and-indications-use
For a more in-depth look at Developing Usable Instructions For Use for Medical Devices, Med Device Online has a great article.
