Dr. Jeff Hersh
Q: Does the FDA regulate medical devices or only drugs? If it does regulate them, is this preventing new inventions?
A: Yes, the FDA closely regulates medical devices, as it does medications. In general, the FDA requires medical device manufacturers to show that their products are safe and effective (similar to what is required for medication approval), which is noted to mean:
“There is reasonable assurance …. based upon valid scientific evidence, that the probable benefits to health from use of the device …. outweigh any probable risks.”
There are different pathways to get FDA approval.
- A new (“novel”) medication must go through rigorous testing and clinical trials (as the COVID vaccinations had to) to get approval (even though due to the pandemic emergency the initial authorization of the COVID vaccines was allowed with an Emergency Use Authorization, there is now full approval).
- A generic version of an established medication may only need to do an Abbreviated New Drug Application to show their medication is equivalent to the marketed medication.
For medical devices it is conceptually similar with:
- New (“novel”) devices requiring rigorous testing and clinical trials.
- Devices that are ‘substantially similar’ to already approved devices (for example a new model of an x-ray machine) being approved after demonstrating ‘substantial equivalence.’
The questions of “what is a medication” and “what is a medical device” are of course crucial.
The FDA defines a drug (this is only part of the regulation) as:
“A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”
The interpretation of how to apply this is important. For example, certain dietary supplements are not required to demonstrate they are “safe and effective” as above.
Medical devices are defined to be (this is only part of the regulation):
“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is….. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals…”
The similarity is intentional. Once again, the interpretation of what is a medical device is important. For example, although some software products are medical devices, some which are intended “for administrative support of a health care facility….” or are intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” are not considered medical devices.
Just as the FDA encourages development of new medications which are safe and efficacious, it also encourages development of new medical devices that meet those standards. In fact, more and more “novel” medical devices are being approved by the FDA each year. In 2010 there were 29 novel medical devices approved by the FDA, and by 2020 this number rose to 132 (for comparison there were 21 novel drugs approved in 2010 and 53 in 2020).
The amazing creativeness of what is being invented (both as regulated medical devices and other clever inventions not requiring FDA regulation) is extremely impressive. Here are just a few examples:
Artificial Intelligence (AI) to:
- Help clinicians identify whether an endotracheal tube (a breathing tube placed into the patient’s trachea) is correctly placed.
- Help guide medical professional who may not be experts in ultrasound to obtain quality images of a patient’s heart (echocardiograms).
- Other AI applications (not surprisingly this field is growing rapidly).
- More personalized prosthetics, specifically utilizing 3D printing to make them to order!
- Scientists from the Israel Institute of Technology have taken this one step further, creating e-Nable which is a “global community of Digital Humanitarians” that volunteer to use their own personal 3D printers to deliver free/inexpensive prosthetic hands and arms to those in need (for example growing children who need a prosthetic hand/arm may need to have them replaced periodically as they grow).
- A “liquid biopsy device” (so it analyzes a blood or another fluid sample from the patient) that can do state of the art genetic sequencing to identify specific mutations in a patient’s cancer.
- What may be considered as a version of an “artificial pancreas” for diabetics that can use continuous blood glucose measurements to automatically adjust insulin delivery by an insulin pump.
- A high-intensity focused ultrasound (HIFU) beam focusing device to deliver energy to treat certain bone lesions (osteoid osteomas).
- Invasive catheters (wires that are used in certain cardiac and surgical procedures) that can dynamically change their stiffness (a more flexible may be desired initially to avoid trauma to body structures, and then a stiffer catheter preferred to fine tune the ultimate positioning).
- A clever robotic-like device invented by an engineer to help give more independence to a young girl born without arms (but which can now also help many other patients), allowing her to eat lunch with her classmates (instead of having to go to a special room where an aid would feed her).
Bottom line, there is huge ingenuity and creativity out there, and it is being tapped more and more to create devices to help patients!
Jeff Hersh, Ph.D., M.D., can be reached at [email protected].