Reference: (FDA Medical Device Classes Define, 2014)
The Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act established three regulatory classes for medical devices. The three classes are based on the degree of control necessary to assure the various types of devices are safe and effective.
Class I – These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.
Class II – Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 43% of medical devices fall under this category.
Class III – These devices usually sustain or support life, are implanted or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.
Exempt – If a device falls into a generic category of exempted Class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, the manufacturer is required to register their establishment and list their generic product with FDA. Examples of exempt devices are manual stethoscopes, mercury thermometers and bedpans.
Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA their intent to market a medical device. This is known as Premarket Notification (PMN) or 510(k). Under 510(k), before a manufacturer can market a medical device in the United States, they must demonstrate to FDA’s satisfaction that it is substantially equivalent (as safe and effective) to a device already on the market. If FDA rules the device is "substantially equivalent," the manufacturer can market the device. If the device you are researching has been in commercial distribution before 1976 or is substantially equivalent to a device already on the market, you should search FDA’s 510(k) releasable database.
A primary safeguard in the way FDA regulates medical devices is the requirement that manufacturers must submit to FDA a Premarket Approval (PMA) application if they wish to market any new products that contain new materials or differ in design from products already on the market. A PMA submission must provide valid scientific evidence collected from human clinical trials showing the device is safe and effective for its intended use. If the device you are researching is life sustaining or presents a potential, unreasonable risk of illness or injury, you should search FDA’s Premarket Approval (PMA) releasable database.
Investigational Device Exemption (IDE) - An IDE allows the investigational device to be used in a clinical study to collect safety and effectiveness data required to support a Premarket Approval (PMA) application and in some rare situations a Premarket Notification (510(k)) submission. Only a small percentage of 510(k)s require clinical data to support a marketing clearance by the Food and Drug Administration (FDA). An IDE limits the distribution of an investigational device only to the sites identified in the IDE application. In addition to FDA requirements, clinical studies of devices are also monitored by Institutional Review Boards (IRB) located at hospitals or other facilities where the clinical studies are conducted. An IRB is composed of medical experts and lay persons.
The purpose of an IRB's review is to assure ethical principles are in place for patient selection criteria, and that adequate informed consent information exists to identify the risks to patients. The IRB acts as FDA's surrogate to oversee the protection of human subjects who participate in the clinical studies. The initial risk determination of a clinical study and/or device is made by an IRB in most cases. The IRB determines if a device/clinical study is significant risk or non-significant risk. The FDA can overrule any risk determination made by an IRB. If the IRB determines that a device/clinical study is significant risk the applicant must submit an IDE application to the FDA. The FDA must approve the application prior to the applicant enrolling patients in the clinical study. If the IRB determines that the clinical study/device is non-significant risk the applicant can enroll patients without submitting an IDE application to the FDA. The clinical study will be monitored by the IRB under the abbreviated requirements of the IDE regulations in 21 CFR 812.2(b).
FDA will not disclose the existence of an IDE because the information is considered confidential.