This article is a continuation of: “What Do Dental Floss, Bedpans, and Pacemakers Have in Common?”, and discusses the three types of medical device classifications and how to register and list those devices with the FDA.
FDA’s classes of medical devices:
“The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of medical devices.”
The device classification is broken up into three regulatory classes (Class I-III), which is “based on the level of control necessary to assure the safety and effectiveness of the device”. To determine the device classification, the FDA looks at “the intended use of the device and also the indications for use“. According to the FDA’s Guidance on Device Regulation, the intended use of a device “means the general purpose of the device or its function, and encompasses the indications for use”. Indications for use is “a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended”. (21 C.F.R. §814.20(b)(3)(i)). The class for which your medical device would belong to, determines the type of pre-market submission or application that is required for FDA clearance to sell the medical device in the United States.
Class I medical devices are considered to be low risk devices, which allows them to be subjected to the least amount of regulatory controls. These devices only need general controls to determine the safety and effectiveness of the device. Most Class I medical devices are exempt from the Premarket Notification (510(k)), however this class does require an Establishment Registration for manufacturers and importers; and also requires the device to be listed. A good example of a Class I medical device would be a band-aid, because it has a low risk of harm to the user.
Class II medical devices are considered to be intermediate risk devices. Most Class II medical devices require a Premarket Notification (510(k)). “A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA.” (21 C.F.R. §807.92(a)(3)). There is no 510(k) form, but there are certain requirements that must be met for a 510(k) submission, which can be found at 21 C.F.R. §807. Once a submitter receives a letter from the FDA stating that the device is substantially equivalent then the device is cleared for commercial distribution within the United States. An example of a Class II medical device would be a powered wheelchair, because it would pose an intermediate risk of harm to the user.
Class III medical devices are the highest risk devices because they generally support or sustain human life, which make them subjected to the highest levels of regulatory control. These devices typically have to be approved by the FDA before they can be marketed inside the United States. Most Class III medical devices require a Premarket Approval (PMA). A PMA is “the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices…and are the most stringent type of device marketing application required by the FDA”. An example of a Class III medical device would be a defibrillator, because it has a high risk of harm to the user.
The FDA Registration Process:
Any owner or operator of an establishment that is involved in the production and distribution of medical devices, and are intending to distribute those medical devices within the United States, must register annually with the FDA. Most of the establishments that register are also required “to list the devices and the activities performed on those devices at the establishment”. The FDA has a list of which domestic and foreign establishments should register and list their devices.
There is an annual establishment registration fee, and for the year 2017, the fee would be $3,382. The initial registration must be within 30 days of initiating any activity requiring registration, and also includes processing devices for exportation and importation of devices into and outside of the U.S. Foreign establishments should register prior to exporting their devices into the U.S. The FDA will not process the registration or assign a registration number until the establishment has notified the FDA that production will begin within 30 days of the registration. If an establishment is registering for the first time, then they should submit both the registration and listing forms together.
If you are an establishment that is involved with the production and distribution of medical devices and are looking to market within the United States, then contact firstname.lastname@example.org to make sure that your establishment properly registers and lists their medical device with the FDA.