Hi Tamiko,
There indeed are many ethical and moral thoughts around the use of devices, what can be provided to physicians, and what may be used by healthcare professionals and non-healthcare professionals. For me there are two paths for a medical device (well and pharmaceutical product as well) and a semi-path, so 2.5 paths that are clear to me.
One: The device satisfies all of the regulatory requirements for the country - as there are different classifications this can lead to multiple pathways for a medical device to be legally marketed, sold, and used. This can be an approval, clearance, registration, etc., along with the myriad of other activities which may need to occur, e.g. quality system, in-country representative, labelling, etc.
Two: A device which does not meet the regulatory requirements can be used with a patient as long as there is a valid investigational process in place, such as a clinical trial, Ethics Committee approval, IRB approval, device properly labelled, etc.
Half: The medical device is a "custom" device which is needed for a specific patient for a specific condition. There are definitions for custom devices where these are one-of-a-kind, not mass produced, less than 5, etc., but they really are specific to a patient and that patient's needs as viewed by the healthcare professional.
I know it may seem stark, but for me in most countries it is quite clear when a medical device can be used with/on/in a human person (and maybe even animals).
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 17-Nov-2022 12:41
From: Tamiko Eto
Subject: Is it legal to use NON-FDA approved or cleared novel/investigational medical devices as standard of care?
The answer to my question, for the past 20 years, I have always believed to have been "no". It is not legal to use investigational or novel medical devices on patients without FDA approval or clearance (or at least some kind of "FDA finding" (e.g., 510k; an IRB's Non-significant risk determination; an exemption from FDA, etc.).
But there are many who believe that this is not the case, and that such investigational devices need not go through any regulatory process to enter clinical workflows, "so long as the hospital wants to use them".
Is this accurate?
I come from it from a regulatory background, but from an ethical one and as a potential patient of this hospital, I would have a lot of concern if my standard of care was done on medical devices that have not been determined safe or effective by the FDA.
Thoughts?
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Tamiko Eto
Research Compliance and IRB Manager
Milpitas CA
United States
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