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What is a Medical Device as Defined by the FDA?

EVS Metal's Amada HG 1003 ARs creating complex bends on a defibrillator base.
EVS Metal’s Amada HG 1003 ARs creating complex bends on a defibrillator base.

One of the reasons EVS Metal is classified as an essential business by the Department of Homeland Security during the COVID-19 pandemic is that all four of our sheet metal fabrication facilities manufacture critical medical devices. But what is considered a medical device by the FDA? 

What does the FDA consider a medical device?

The FDA defines medical devices in several ways. They can be any instrument, including machines, implants, and other related articles, as well as components, parts, and accessories, that is recognized in the official United States National Formulary, or the U.S. Pharmacopoeia. A medical device can also be categorized as such based on the device’s intention. If it’s meant to be used in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals, then it can also be considered a medical device. Finally, if a product is intended to affect the structure or function of a human’s or animal’s body, it can be called a medical device, too. 

How are medical devices classified?

The FDA recognizes three different classifications for medical devices; those with the lowest risk to human or animal health fall into Class I, while those with the most risk are considered Class III. The more invasive a product, generally speaking, the more likely it is to be classified as a III. Only 10% of approved medical devices are categorized as Class III. 

While most people probably think of medical devices as being very complex, expensive or invasive — like pacemakers or ventilators — there are many that are quite simple. For instance, a classic thermometer, a wooden tongue depressor, and nitrile or latex gloves are all considered medical devices, albeit safe and common ones that can be found on pharmacy shelves. 

What are some examples of medical devices in each FDA class?

  • Class I; Low Risk: Sterile bandages (“Band-Aids”), gauze, toothbrushes, manual wheelchairs, exam gloves, dental floss
  • Class II; Moderate Risk: Hypodermic needles, contact lenses, catheters, sutures, electric wheelchairs, infusion pumps (ex. chemotherapy), x-ray machines
  • Class III; High Risk: Implantable defibrillators, coronary stents, orthopedic implants, heart valves

Interestingly, ventilators — products that have been featured extensively due to potential shortages — generally fall into the Class II categorization, although there are types of ventilators that are more invasive and are classified as Class III. Like all Class III devices, these ventilators would be required to go through clinical trials before being approved for sale.

U.S.-Based Medical Device Fabrication and Manufacturing

EVS Metal manufactures medical devices at sheet metal fabrication facilities in New Jersey, Texas, Pennsylvania and New Hampshire. This includes parts for and finished products like ventilators, hospital medical carts, and vaccine manufacturing and research equipment. We offer in-house design and engineering assistance for new devices; prototype fabrication; finishing, including #8 mirror; as well as assembly, integration and delivery by EVS’ company fleet or by common carrier. Requests for complimentary project quotes can be submitted online or by calling 1-888-9EVSMET.

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