Regulatory Open Forum

 View Only
  • 1.  Is it legal to use NON-FDA approved or cleared novel/investigational medical devices as standard of care?

    Posted 17-Nov-2022 12:42
    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?

    ------------------------------
    Tamiko Eto
    Research Compliance and IRB Manager
    Milpitas CA
    United States
    ------------------------------


  • 2.  RE: Is it legal to use NON-FDA approved or cleared novel/investigational medical devices as standard of care?

    Posted 18-Nov-2022 02:21
    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).

    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    ------------------------------



  • 3.  RE: Is it legal to use NON-FDA approved or cleared novel/investigational medical devices as standard of care?

    Posted 18-Nov-2022 08:40

    Hi Tamiko
    this sounds like a question about the difference between medical care by a physician and marketing of a product by a company. If the former, a physician (MD in the US) can use whatever they want to treat the patient. If the later, a company must have regulatory approval, clearance or must ensure safety and performance before marketing or use (for lowest risk devices, drugs, even foods).


    This is not a belief or an ethical question nor is this a hospital decision, this is likely a legal question based on the medical practice license (in the US) given to individual physicians who care for individual patients (other countries may not give a "medical license" but they typically do regulate medical practice differently than commercial product marketing). 

    Not sure if this answered your question. Please clarify if not.



    ------------------------------
    Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
    President and CEO
    Frestedt Incorporated (www.frestedt.com)
    Saint Louis Park MN
    United States
    612-219-9982
    jf@frestedt.com
    ------------------------------



  • 4.  RE: Is it legal to use NON-FDA approved or cleared novel/investigational medical devices as standard of care?

    Posted 18-Nov-2022 10:06
    So, let's say this hypothetical very large healthcare company likes to make their own hypothetical medical devices "in-house" because they have lots of "creative and innovative" physicians who act as researchers on the side like to apply for all sorts of funding so that they can dabble with making diagnostic software... and this hypothetical company decides to run some tests on its hypothetical medical device using large amounts of retrospective data, and then they call their test a "clinical trial" (though it is purely a retrospective data dump, and nothing prospective or "real world"). Then they decide they'd like to put it into standard of care at ALL of their Emergency Departments nationwide (hundreds of hospitals) to treat and diagnose time-critical conditions like... I dunno.. hypothetically speaking, sepsis, stroke, etc... and so they just use it without saying anything to the FDA, and they never got IRB approval or a non-significant risk device determination from a review board.

    So... that's the hypothetical scenario I'm thinking of.

    ------------------------------
    Tamiko Eto
    Research Compliance and IRB Manager
    Milpitas CA
    United States
    ------------------------------



  • 5.  RE: Is it legal to use NON-FDA approved or cleared novel/investigational medical devices as standard of care?

    Posted 19-Nov-2022 10:08

    Sounds like something similar to this... regarding Clinical Decision Support software (the subject of your hypothetical scenario), I'd point you to the recent final guidance from FDA on the topic, which while controversial does include information on FDA's interpretation of the regulatory status of such products.

    Regardless, best of luck - this is an (ongoing) area of significant regulatory ambiguity (particularly in the US) and doesn't seem to be clearing up any time soon!



    ------------------------------
    Jonathan Amaya-Hodges
    Director, Technical Services
    Sharon MA
    United States
    ------------------------------



  • 6.  RE: Is it legal to use NON-FDA approved or cleared novel/investigational medical devices as standard of care?

    Posted 19-Nov-2022 10:49
    It also sounds like something similar to Laboratory-Developed Tests, which are allowed in the lab that developed them but become subject to controls if they are transferred to a second site. I don't know if FDA would apply similar rules, but the level of risk seems significant in both cases.

    ------------------------------
    Anne LeBlanc
    United States
    ------------------------------



  • 7.  RE: Is it legal to use NON-FDA approved or cleared novel/investigational medical devices as standard of care?

    Posted 19-Nov-2022 14:59

    I thought about that too, Anne.  Even if it's not exactly applicable, it's a good analogy. 

    Best regards,

    Ted