All medical devices manufactured, sold, repackaged, or imported within the United States must meet FDA standards. Below are the three-tiered medical device classification systems that many medical device manufacturers see when making their products.
Here the FDA states “that a Class I medical device, as well as Class II and III, are “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or another similar or related article, including a component part or accessory” that’s recognized as a pharmaceutical or supplement, intended as a diagnosis, cure, or preventive treatment of a disease, with the intention to affect the structure of a human or animal body” (bmpmedical.com).
How do you classify a medical device you might ask yourself. The FDA has compromised a list of 1700 medical devices grouped in 16 medical panels. Medical panels are organized by “such as Cardiovascular devices or Ear, Nose, and Throat devices” (fda.gov). To categorize your medical device by class is all about the risk. The higher the risk the more regulatory control it has.
Class I (low to moderate risk)
Class I is primarily made up of non-invasive devices and can be registered with the FDA in one week or less. These devices include tongue depressors, electric toothbrushes, elastic bandages, and stethoscopes.
In essence, these devices do not need FDA clearance before marketing the use of the product or device (exempt from 510(k)), but the manufacturer of the product needs to register their company along with the product.
Class II (moderate to high risk)
Class II medical device classification has a moderate to high risk to the patient or user. Devices in this category must have general and specialty regulatory clearance by the FDA. Some devices include contact lenses, catheters, and powered wheelchairs.
Class II medical devices can be registered in 6 months, but that time frame depends on the complexity of the device being submitted.
Class III (high risk)
Class III medical devices are used to sustain life. These account for 10% of medical devices and pose a higher risk to patients. These devices include defibrillators and implantable devices such as pacemakers.
For Class III devices, the FDA requires backed scientific evidence and extensive research before even submitting information to the FDA. The approval process for Class III devices takes up to 8 months or more.
Stone Medical and Swiss Technologies of New England is happy to assist you in your next medical device project, contact us today at sales@swisstechnologiesne.com.
Resources:
https://bmpmedical.com/whats-difference-fda-medical-device-classes-2/
https://www.twi-global.com/technical-knowledge/faqs/what-is-the-medical-device-development-process