Hello Anon,
The simple answer to your first question is yes. However, it depends on how the regulatory status was initially established or would be established for a product such as an electronic injector. This type of product would be considered a medical device as a delivery mechanism for a drug product/medicinal product. In response to the second question, the answer is well beyond answering in a simple forum post. You might want to seek some further expert opinion on 'supportive documentation' because an electronic injector would most likely be considered a finished medical device in its own right. There are many aspects of design, manufacturing, labelling, and others which would be needed for supportive documentation.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 22-Jul-2022 10:57
From: Anonymous Member
Subject: Electronic injectors storage at home
This message was posted by a user wishing to remain anonymous
Hello RAPS community,
My question is the following:
To enable sorage of a resusable electronic injector at home (which is part of drug-device combination product) for the US, does CDRH likely going to tag this as a "Medical Device for Home Use" even if we do not have in our label the home/self-injection or we do not need to mention anything in our labeling concerning the place for the device storage as long as it is not the patient who does the injection ?
If this is considered as a "Medical Device for Home Use", what kind of supportive documentation do we need to include in our file to facilitate this (in terms of labeling, documentation...)?
Thanks in advance.