MediSurge is an FDA Registered medical device company that handles all aspects of the design, development, and manufacturing process. We are focused on creating high quality medical devices that ultimately improve patient care and outcomes. Because we design and develop a wide variety of devices, our team has extensive knowledge of industry regulations and device classifications.
What is a Medical Device?
According to the U.S. Food and Drug Administration (FDA), a “medical device” is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory” that is intended for the use of diagnoses, cure, or prevention of disease in man or other animals.
There is a large range with medical devices when it comes intended use and indications for use. Devices like tongue depressors, thermometers, gloves, or bedpans are simple and typically low risk for patients, whereas complex devices like pacemakers or surgical devices carry much more risk.
The FDA regulates any and all medical devices that are manufactured, repackaged, relabeled and/or imported in the country. Under the FDA, there is a three-tiered classification system that is based on risk to patients and the level of control necessary. The three classes are Class I, Class II, and Class III, which is rather straightforward.
Not sure which class your device falls under? Here is a helpful breakdown:
A Class I medical device is something that has a low to moderate risk for patients. Because of that, these devices also have the least regulatory control. Devices that fall under this category are not intended to support or sustain life. Examples are bandages, examination gloves, stethoscopes, or bedpans.
Devices that fall under Class II are those that pose a moderate to high risk for patients or users. The majority of medical devices on the market are considered to be Class II. Examples of these devices include pregnancy test kits, surgical drapes, or powered wheelchairs. These devices are subject to special labeling requirements and require additional testing and surveillance.
Class III devices are items that are considered to have a high risk for patients or users. These devices are typically used to support or sustain life, are implanted within the body, or pose extreme risk. Devices that would fall within this class are pacemakers, HIV diagnostic tests, defibrillators, and more. These devices are subject to the highest level of control.
Understanding the different medical device classes and the required approval processes or testing for each is key for success in the industry. Medical devices have the ability to save or positively impact someone’s life, and because of this, we don’t take our work lightly.