I have a device in which I have to do labeling/comprehension testing? Has anyone done this before? I really don't know what to do.

labeling/comprehension testing? Can you clarify? COmprehension as in is it clear english? or is the type readable?


Labeling "testing" I've done has been more along the lines of adhesion, alignment, claritity of the text (not blurred or smeared, no missing letters or chunks, etc).
I used to have to do a lot of proof reading and have looked into video inspection systems for print on bottles.

labeling/comprehension testing? Can you clarify? COmprehension as in is it clear english? or is the type readable?


Labeling "testing" I've done has been more along the lines of adhesion, alignment, claritity of the text (not blurred or smeared, no missing letters or chunks, etc).
I used to have to do a lot of proof reading and have looked into video inspection systems for print on bottles.

I'm pretty sure that lable comprehension is something that must be qualified when a pharmaceutical manufacturer wants to switch a drug from prescription-only to OTC. The FDA requires studies to be conducted to insure that the labeling is comprehensible to the general public. There may be other instances where labeling comprehension is also an issue.

I need to complete label studies to show comprehension of labels by average people. The labels should be comprehensible at an 8th grade level. I guess, to make sure that an average person can understand instructions/labels with out harming themselves or using the device improperly. This came up because my predicate device is a Rx device and mine is an OTC device. I guess I don't really know how to go about it.

I need to complete label studies to show comprehension of labels by average people. The labels should be comprehensible at an 8th grade level. I guess, to make sure that an average person can understand instructions/labels with out harming themselves or using the device improperly. This came up because my predicate device is a Rx device and mine is an OTC device. I guess I don't really know how to go about it.

Other than my lucky guess about what you were looking for, I really don't know much about it. Perhaps one of our friends here in the Cove can shed some light. A Google search on label comprehension (http://www.google.com/search?hl=en&q=label+comprehension) turns up some information which could be useful.

You´re talking about usability (human factors) studies, if i understand it correctly. You should talk to a medical device usability expert, because these tests are not as straightforward as it may seem.

Just as an example, the new version of IEC 60601-1 has requirements for comprehension in which the documents and other labelling of the devices have to de compatible with the level of expertise required by equipment operators. Also, the standard requires an usability analysis and file (based on IEC 60601-1-6 - usability).

Hi Scott,
Since you have work in plastics and you seem to have a great knowledge in regulatory...Are there materials like typs of plastics which have been FDA cleared? If so, let say that my device is made out of "known plastic A" and this is only part of my device that comes into contact with a person skin. Do, I still have to do a Biocompatability test? cytotoxicity, sensitivity, irritation? (kind of like how active ingrediants are cleared for drug usage).
thank you,