Hello-
The off label usage in the initial report- is it still off label or have you changed labeling accordingly? Because any 'main' use of the device must be on its labeling anything not on the label no matter how close it is to the approved labeling is still off label.
A CER is to provide scientific and clinical evidence that the device meets safety & performance requirements for the use mentioned in its labeling. I'm confused why FDA would be concerned about your CER because a CER is to support a CE marking in EU. Keep in mind that off label in reality is not entirely black & white. This is true when you have a device with broad indication (eg: laser based surgical instrument for removing tissue, not specifying any kind of tissue). Obviously any data you find will have specific tissue type- orthopedic, cardiovascular, nervous etc. You can and should include this data and while technically it is off label because you don't mention tissue type in your labeling, but the use is not deviant. But if the device is cleared only for adults and you find data on use in pediatric population, then it is off label. Same goes for any contraindications on the labeling. This data may or may not show up based on how you perform your searches. However off label uses that you find in your MDRs and MDVs must be included in the CER with appropriate justification/corrective action.
So ,whether or not you include off label data depends on your device indication, labeling and kind of off label use. Ample off label use leading to complaints/serious events could indicate a gap in physician/patient training and labeling/design controls/risk analysis which must be fixed. Its fair game to include off label use that generates scientifically valid data (adhering to PICO process of querying) that
directly supports your S&E claims. And you can definitely use off label data to expand an indication. To summarize, you don't go looking for off label data in particular but use an exhaustive, non-biased search in your device's therapeutic/diagnostic area of use, covering as many databases as you can and weigh in on each piece of clinical information.
Hope this gives some direction.
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Vidyalakshmi Jayaraman
RA specialist
MA
United States
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Original Message:
Sent: 21-Dec-2017 16:58
From: Anonymous Member
Subject: Clinical Evaluation Report and off label usage
This message was posted by a user wishing to remain anonymous
Hello,
A general question about updating the Clinical Evaluation Report. The initial report considered an off label usage ( which is the main use of this device that physicians implement it for). Am I required to consider this off label use when doing my yearly update of the CER? For example, should I consider all of the extensive literature publications / clinical trail.gov. results for the off label use of this product? Management is concerned that if I address off label use in the update to the CER, there will be negative repercussions from the FDA because this product is not labeled for this use- please weigh in!