Is There Ever a Time When a Class I or II Device Need not Comply with OTC Regulations on Labeling?
Is There Ever a Time When a Class I or II Device Need not Comply with OTC Regulations on Labeling?
Question
Does the label on the primary and secondary pack of a Class I or II device need to comply with the OTC regulation when the device is always recommended (not necessarily prescribed) to the user by a medical professional?
Answer
If the device is sold over-the-counter (OTC) without a prescription (even if recommended by a medical professional), if must comply OTC regulations. The requirements for medical device labeling can be found in 21 CFR Part 801, click here to view. FDA's guidance on the content needed for device labeling was developed many years ago. The document, "Device Labeling Guidance (G91-1)" (last updated 1991), is available by clicking here.
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