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  • 1.  FDA-cleared intended use vs. state law/policy

    This message was posted by a user wishing to remain anonymous
    Posted 30-Mar-2021 16:34
    This message was posted by a user wishing to remain anonymous

    I am trying to get a sense of what the obligations of the manufacturer are, if any, in instances where US state law does not match the cleared intended use of a device. For example, I (manufacturer) have a device that is cleared to be used by a healthcare professional, defined in the 510(k) as either Person A or Person B. I've learned that some states have laws stating that only Person A can use the device. From the perspective of the FDA, I could see that being considered the practice of medicine, i.e., not within the FDA's scope to consider. But what about from the perspective of those specific states? Do I, as the manufacturer, need to know who in each state can buy and use the device and only sell to those who would be considered Person A? Do I need to change the labeling to reflect the state-approved user of the device in each state? Or is it up to the practitioner to know their local laws and decide for themselves if they are the appropriate user of the device?

    Any input would be greatly appreciated!


  • 2.  RE: FDA-cleared intended use vs. state law/policy

    Posted 31-Mar-2021 02:27

    Hi!

    First, let me say that the following does not constitute legal advice and you should not act or refrain from acting on the basis of the information provided below without first seeking legal advice from counsel.

    Now on to some thoughts on your question -

    The short answer is that FDA's medical device regulations "preempt" state law on the issue. Preemption is the notion that when state and federal law conflict, federal law wins out (see the "Supremacy Clause", US Constitution, Article VI, Section 2). The Supreme Court addressed this issue directly in Riegel v. Medtronic. In Riegel, the Plaintiff was injured during cardiac surgery. He then sued the manufacturer of the device used in the surgery, Medtronic, for negligence in the design, manufacture, and labeling of the device. Medtronic argued that Riegel could not bring these state-law negligence claims because they were preempted by Section 360k(a) of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act. The MDA establishes states:

    "[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement… which is different from, or in addition to, any requirement applicable under this chapter to the device and… which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter."

    The Riegel court ruled that the MDA preempted state common law claims for defective devices. Riegel's negligence and strict liability claims relating to the safety and effectiveness of the catheter were based on New York's requirements and were therefore "different from, or in addition to" the federal requirements.

    At first look, it seems that the state law at issue in your case might be "different from, or in addition to" the federal law on the issue and therefore preempted. That being said, state law preemption issues are exceedingly complex and require a pretty close analysis, so I would recommend legal counsel.

    Feel free to reach out if you would like to discuss further.

    Best,

    Josh



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    Joshua Van De Riet
    Modi'in
    Israel
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    Original Message


  • 3.  RE: FDA-cleared intended use vs. state law/policy

    Posted 31-Mar-2021 04:15
    Hello Anon,

    Indeed there are instances where local state law in the United States or even further regional law may restrict use of medical devices and IVD products depending on intended use.  As an example, many aesthetic products (re-surfacing devices or laser) may require either a physician use in some states or a licensed beautician in other states.  Similar there are some IVDs which require certain license based on state and type of IVD test, such as Point of Care product versus CLIA high complexity device.  This is fairly limited to types of devices, meaning most general surgery or hospital products may not have any local state regulations. There are also some states where additional registration of facilities such as x-ray manufacture or laser devices need to be made, e.g. Texas.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: FDA-cleared intended use vs. state law/policy

    This message was posted by a user wishing to remain anonymous
    Posted 31-Mar-2021 16:41
    This message was posted by a user wishing to remain anonymous

    Hi Richard,

    Thanks for your response. In your example of the re-surfacing device or laser, do you think the manufacturer should produce different IFUs with intended use statements that are tailored to each state, i.e., one for states that limit device use to a physician and another for states that limit device use to a beautician? Or should the manufacturer just use one IFU leave it to the specific states to know who the appropriate users are?
    Original Message


  • 5.  RE: FDA-cleared intended use vs. state law/policy

    This message was posted by a user wishing to remain anonymous
    Posted 31-Mar-2021 16:42
    This message was posted by a user wishing to remain anonymous

    Hi Josh, 

    Thanks for your input. It does seem quite complex. Another factor that adds further complexity to the matter is that the relevant professional societies have started releasing very clear position statements on the matter, but the statements point (in my non-legal opinion) to very vague state laws that seem like they could be interpreted a number of ways. It definitely seems like engaging legal counsel may be the best route to take.
    Original Message


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