The medical device labeling must be consistent with the class and the claims made about the device.
The medical device labeling must be consistent with the class and the claims made about the device. A label is a
‘display of written, printed, or graphic matter upon the immediate container of any article…’
The term ‘immediate container’ does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear ‘on the outside container or wrapper, if any there be, or the retail package of such article, or is easily legible through the outside container of wrapper.’
Incorrect labeling, for example using the words “surgical” or “sterile” on a level 1 or level 2 gown could force the device to be treated as a level 3 or 4 product and require premarket approval. Such terms require a more extensive analysis of test results offered in the 510(k) process to prove those claims.
Based on the chosen classification we will examine the labeling and identify any inconsistencies or recommend additional language that needs to be added to satisfy FDA requirements.