No matter what your product is, at some point in your regulatory journey you will need to appropriately determine your product’s intended use, indications for use, and instructions for use. For most people, these three items sound like they should mean the same thing, but for the FDA, they are all different. Your company must use these terms correctly because incorrect use of them could lead to issues with the FDA granting your device approval or clearance.
The first of these terms that will typically come up in your development process is intended use. The FDA defines intended use as, “the objective of the persons legally responsible for the labeling of devices”. Put in simpler terms, the intended use is what the purpose of your device is. Your intended use can impact the regulatory pathway that you need to follow, so it is important to be accurate and clear when stating your intended use.1
Next comes indications for use. This is defined by the FDA as, “a general 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”. This essentially begs the questions: Who will be using your product, and why will they be using it? Changes in your indications for use typically will not alter your regulatory pathway too drastically, but it is still important to be clear and accurate in this statement. Providing the FDA with your indications for use will help them have a clearer picture of your product, which ultimately will lead to your product getting to market sooner.2
Finally, the instructions for use (IFU) is defined by the FDA as, “detailed, action-oriented, step-by-step written and visual instructions provided in a patient-friendly manner”. This one is easier to understand – essentially how the patient uses your product. While the idea behind this term is more intuitive than the others, it can still get tricky because the FDA has strict guidelines for how to prepare your IFU. This is because the IFU will be included with every product you manufacture, so the FDA needs to ensure that all patients are getting accurate and clear information. The FDA requirements for IFUs include the formatting, the content, the graphics, and the warnings.3
In summary, these three terms should answer the questions below,
Intended use = What?
Indications for use = Who and Why?
Instructions for use = How?
While these terms can be simplified, determining each for your product can still prove to be difficult. If your company is having a hard time identifying any of these, our regulatory experts at EMMA International can help ensure that you meet all the FDA’s requirements. Contact us at 248-987-4497 or firstname.lastname@example.org for additional information.
1FDA. (2019, April 19). 21CFR801.4. Retrieved December 8, 2020, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=801.4
2FDA. (2018, September 27). PMA Labeling. Retrieved December 8, 2020, from https://www.fda.gov/medical-devices/premarket-approval-pma/pma-labeling#:~:text=Indications%20for%20use%20for%20a,%2C%20race%2Fethnicity%2C%20etc.
3FDA. (2018, August 31). Guidance on Medical Device Patient Labeling. Retrieved December 8, 2020, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-medical-device-patient-labeling