The FDA has been regulating medical devices since 1938 but with very little oversight. By the 1970s the system could no longer adequately regulate the growing number of types and complexity of devices, so in 1976 Congress passed legislation that provides the framework for our current regulatory system. That legislation was updated in 1990 and 1997.

Risk Categories

Devices are put into one of three categories:

  1. Low risk devices- Low risk devices are not tested. These include items such as band-aids, tongue depressors, crutches.
  2. Moderate risk devices– 90-95 percent of devices on the market are categorized as moderate risk devices. This category includes items such as glucose meters, contact lenses, and solution, some of which can be purchased over the counter. However, class 2 also includes devices which require invasive surgery to be implanted and removed. Some examples include the hardware used to treat spinal issues, and hip and knee joint replacements. Class 2 devices do not require any clinical trial testing. This means that 90-95% of medical devices are never tested for safety and effectiveness because they are cleared for market through a fast track process known as the 510(k).
  3. High risk devices- High risk devices must be life-saving or life-sustaining and include devices such as artificial heart pacemakers. However, this category also includes breast implants. Any device in this category requires only one clinical trial as part of the pre-market approval process. The testing must provide evidence that the device is reasonably safe and effective.


Market Pathways


1.Premarket Approvals

Clinical trials are required of category 3 high-risk devices when there is no predicate device on the market. To meet the requirements for approval to market, the device company must conduct only one clinical trial. The concern for patients is that if the one clinical trial does not include a broad enough demographic, or if conducted only for a short time the results cannot provide efficient reasonable assurance of safety and effectiveness for use in the general public.

2. 510(k) Clearances

Section 510(k) (also known as Pre-market Notification) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify the FDA of their intent to market a medical device at least 90 days in advance. This allows the FDA to determine whether the device is substantially equivalent to a device already placed into one of the above categories.

Most medical devices make it to market after a 290 day 510(k) clearance process. Medical device makers want that fast-tracked to 108 days by 2022. For a De Novo submission (or a novel or new medical device), that time would be extended to 150 days.

Let’s take TMJ (temporomanibular joint) implants as an example.

TMJ replacement entails surgical replacement of the temporomanibular joint with a joint prostheses.

This is a TMJ device-

The FDA considers the TMJ implant substantially equivalent to silicone sheets.

This is a silicone sheet-

In reality, one is surgically implanted; the other is topically applied. Under the 510(k) process, the FDA considers them the same.

The 510(k) looks at lab outcomes on paper and compares them to previously cleared devices. It does not look for the process by which those results were obtained. Medical devices are not tested for safety and effectiveness. The measure used for clearance to market is one of substantial equivalency to a previously cleared device – one that went through the same faulty system and was never tested for safety and effectiveness.

The FDA currently does not have the power to require a medical device maker to fix a defective design flaw that can injure consumers. A flawed medical device can still serve as a “predicate” upon which subsequent devices are cleared.

Public Citizen wrote a comprehensive report called Substantially Unsafe that explains how this process leads to patient harm. In addition, in a 2011 FDA-commissioned report from the Institute of Medicine the committee concluded that “the 510(k) process lacks the legal basis to be a reliable pre-market screen of safety and effectiveness of moderate-risk devices and furthermore, that it cannot be transformed into one”. However, the committee suggested that “the continual use of many of these devices in clinical practice provides reasons for a level of confidence in their safety and effectiveness”. The problem with that assumption is that the United States does not have a well-established method of tracking devices, reporting harm, or collecting those reports in a cohesive way. Until such time that the current system is replaced with something that serves the public’s best interests, it is important to remember that newer is not always better; faster does not make a device safer.


Medical Device User Fee Amendments (MDUFA )

Device user fees were established in 2002 by the Medical Device User Fee and Modernization Act. These fees are paid to the FDA to review applications submitted by companies wishing to market a medical device. The caveat is that 95% of devices are fast-tracked through the clearance process.


12 Questions to Ask When Your Doctor Wants Consent to Use a Medical Device.

The following are 12 questions to ask when your doctor wants your consent to use a medical device, developed by Peter Mullenix. Used with permission.

  1. Do you mind if I record this conversation with my phone so I can have it to refer to when I do my research?
    •  Why? If a doctor knows their consent is being recorded, they will have more reason to more fully and fairly disclose the risks of the procedure. And you won’t have to rely on your memory or your notes when you try to learn more on your own.
  2. Has this device ever been subjected to human clinical trials? What information do you have about those trials? Were they sponsored by the manufacturer?
    • Why? The goal is to get the doctor to think about the true quality of the evidence the manufacturer’s sales reps have provided. Often, studies are simply sponsored by manufacturers, who cherry pick results. Or more often, there have never been human trials. Or there have been, but the quality is low because the trial was not prospective, randomized, double-blind, etc.
  3. Is the way you want to use the device “off-label”? Are there any warnings or contraindications on the device label?
    • Why? Doctors are not regulated by the FDA the way most of us think they are. Many believe they are free to ignore warnings and contraindications without even telling you.
  4. Do you have any written information about this device? What about materials that do not come from the manufacturer?
    • Why? One of the ways device manufacturers ease the burden on doctors is to provide the doctors with patient-facing materials. That way the doctors don’t have to go to the work of analyzing the product themselves. But this is obviously biased information.
  5. What has been your personal experience with the device?  Is there any sort of learning curve?  What is the worst outcome you know of that one of your patients has had with the device? What doctor, other than yourself, do you consider to be most experienced in using this device?
    • Why? The learning curve issue is real, particularly with devices used to perform surgeries. Doctors want to get over the learning curve, and they need willing patients to do that. But no law requires you to be the guinea pig. Find a doctor who has already made it through the learning curve, and let your doctor practice on someone else.
  6. Has the device ever been recalled?  Have you ever received a “Dear Doctor” letter related to the device? Have you checked with the hospital on these issues?
    • Why? Recalls are far more common than most patients know. Moreover, manufacturers often send out “Dear Doctor” letters to surgeons rather than doing recalls. The problem is, the surgeons don’t always get or pay attention to these letters. Your goal is to force the doctor to both ask and pay attention.
  7. What are the risks associated with this device, and do the benefits outweigh those risks? Why?
    • Why? Most doctors will do this in abbreviated form. The key is to ask follow up questions and have them give you specific information about each possible alternative. The doctor already knows what he or she wants to use. But if the choice is obvious, the doctor should be able to articulate why to you.
  8. What are the alternatives to using this device? How was this done before the device came on the market? Are there similar products from other manufacturers on the market? If so, why this specific device?
    • Why? New does not always mean better. Often, newer devices will offer benefits that, in the grand scheme of things, really don’t matter that much. Worse, they will sometimes also bring new risks that the more traditional procedures/older devices help you avoid.
  9. Do you expect to have any representatives from the manufacturer present during the procedure?  If so, why is that?
    • Why? This is another way to find out whether there is a learning curve. Often manufacturers have their sales reps present at surgeries when the doctor is new to the device. Or, they do it when the reps have a particularly strong relationship with the surgeon. That should also raise your eyebrows, because those relationships are often produced by small, repeated, favors, gifts, and sometimes even outright bribes. Sometimes the surgeon has a direct financial incentive to use the device. Sometimes the surgeon has been flown someplace sunny to “learn about the device” on the manufacturer’s dime. These relationships cloud the surgeon’s judgment, meaning you are not necessarily getting a fully objective view about what device is best for you.
  10. Have you ever received any gifts or financial benefits from the company that makes this device? What is the name of that company? 
    • Why? Same as last question. And be particularly thorough on this issue, because the ways companies pamper and pay doctors can be extraordinarily varied. Companies spend an enormous amount of money to make the doctors like them, and they do it for one reason: it works. Then, once you’ve gotten your answer from the doctor, check to see how candid he or she has been by searching for him or her on
  11. Will you please record the procedure in which you use the device, and send the video to me?
    • Why? A doctor who knows he or she is being recorded will be more careful. Plain and simple. I think doctors should be required to offer recordings to patients. But until they do, we should all ask. A doctor who refuses this request needs to explain why.  (Imagine if your lawyer told you you were not allowed to watch opening statements or read deposition transcripts. Imagine if your contractor told you you could not be there while the work on your home was done.)
  12. What is the cost of this device and will insurance cover it?
    • Why? Most doctors do not think they are required to tell you this information if you don’t ask. But if you’ll end up paying thousands more, and there is little actual benefit, it pays to ask the question.