Label comprehension studies test how well a typical consumer can understand the labeling for an over-the-counter (i.e., non-prescription) drug or medical device. The labeling may include the product box or the instructions for use found inside the package. The idea is to reveal areas on the label(s) where vital consumer information could be presented in a clearer or simpler way.
The FDA wants proof that ordinary individuals, including people with lower literacy, can understand and apply the information on the labels on their own, without the help of a healthcare professional.
These studies are often required when medical device or drug manufacturers are applying for an FDA pre-market authorization for their product (i.e., when submitting a 510(k). The FDA may require a label comprehension study in the following situations:
- when a medical device or drug product switches from prescription to over-the-counter (OTC) status;
- when a product is newly introduced;
- when a product approved abroad (E.U., Canada, etc.) is being introduced in the U.S.;
- when there is a new indication or target market;
- if changes are made in directions or warnings; or
- if there are other substantial changes in formulation or dosing.
Label comprehension studies may be conducted in parallel with self-selection studies, simulated use studies, usability testing, and other human factors studies.
Label comprehension studies need to be carefully designed and well implemented to meet the FDA’s rigorous expectations. It is critical to follow the FDA’s Guidance for Industry Label Comprehension Studies for Nonprescription Drug Products. Prior studies, called predicates, also serve as a great source of information about specific product study designs.
Preparing a 510(k) submission for the FDA is no small task. It can be helpful to turn to experts (like us!) to take care of designing and conducting an FDA-grade label comprehension study for your OTC product.
Here are 5 insider tips to consider when conducting a label comprehension study:
1. Start small.
It’s best to take an iterative approach and begin with an exploratory qualitative study. Interview a small group of typical users to test and improve your product labels prior to implementing your full quantitative label comprehension study.
2. Consult experts.
Consult statistical experts when designing your study protocol and sample needs to ensure you have the power you need to meet the FDA’s requirements. There’s a lot to consider when preparing to recruit a diverse, representative group of participants with varying levels of literacy.
3. Consider the user.
Pull in experts in questionnaire design to help develop easy to understand, non-biased questions that directly target the comprehension needs for your labeling. Experience in survey question wording is invaluable here. The most common pushback that we see from the FDA to a user comprehension study protocol relates to biased question wording.
4. Iterate!
Use that iterative approach to help design your questionnaire too. While you work on improving your label content, use the same qualitative design to trial your study protocol and survey questions. Use the participants’ insights to optimize your questionnaire and ensure that it is measuring their comprehension effectively.
5. Get the opinion of an FDA expert.
Run your study by a certified regulatory expert (with FDA experience) when you are designing your label comprehension study. Regulatory experts will understand the nuances for how the regulation is applied to your particular product. SoundRocket can help connect you with a certified regulatory expert if you need.
“If there is one thing about FDA work that I have learned, there are always exceptions and reasons why different requirements may need to be met.” – Scott Crawford, SoundRocket
When done properly, user or label comprehension studies help ensure typical consumers will know how and when to safely and effectively use an off the shelf drug or medical device. And while they may be required to meet the FDA’s needs, these studies have a wonderful advantage of making your product better than ever before. In fact, some may find a label comprehension study to be an effective way to improve their product regardless of regulatory needs.
If you are working on an FDA pre-market (or 510(k)) submission for your OTC medical product and you need to perform a label comprehension study, let’s chat! Our multidisciplinary and experienced team of health communication experts and survey methodologists is here to help.