United States Food and Drug Administration Regulation of Ophthalmic Devices
The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products.
An instrument or machine is considered a device if it is intended for use in the diagnosis of disease or in the cure, mitigation, treatment, or prevention of disease, or if it affects the structure or any function of the body and does not achieve its primary intended purposes through chemical action and is not dependent upon being metabolized for the achievement of its intended purposes. This definition provides a clear distinction between a device and other FDA-regulated products.
The Center for Devices and Radiological Health (CDRH), 1 of 7 FDA centers, is responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the United States.
Classification of Devices
The Medical Device Amendments to the Food, Drug, and Cosmetic Act were enacted in 1976. These amendments categorized device types into 1 of 3 classes (Class I, II, or III) based on risks posed by the device. The class to which a specific device is assigned determines, among other things, the type of premarketing submission required for the device to be legally marketed.
Classification of medical devices identifies additional regulatory control, if any, that is necessary to assure the safety and effectiveness of a specific device. Medical devices are classified into Class I, II, and III such that the risk that a device poses to the patient and/or the user is a major factor in the class to which it is assigned. Regulatory control increases from Class I to Class III.
Class I devices are those for which general controls alone are sufficient to assure the safety and effectiveness of the device. They are generally low-risk devices and need only conform to general controls to provide reason-able assurance of safety and effectiveness. The provisions of general controls include prohibition of adulterated/misbranded devices, manufacturer registration and listing requirements, good manufacturing practices, and record keeping. Most Class I devices are exempt (subject to limitations defined in the regulations) from premarket notification (510[k]). Class I devices are subject to the least regulatory control. Ophthalmic examples of Class I devices include most visual acuity charts, perimeters, manual surgical tools, and topographers.
Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and for which existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance. Ophthalmic examples of Class II devices include most vitrectomy and phacoemulsification instruments, tonometers, slit-lamp microscopes, glaucoma lasers, and implantable glaucoma devices for the refractory patient population.
Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or that present a potential, unreasonable risk of illness or injury. Ophthalmic examples of Class III devices include IOLs, excimer lasers, endotamponades, viscoelastics, and implantable glaucoma devices for the nonrefractory patient population.
Most Class I devices and a few Class II devices are exempt from the 510(k) requirements of the Act, subject to the limitations to exemption found in each classification chapter (eg, 21 CFR 886.9). If a manufacturer’s device falls into a generic category of exempted type devices and meets the exemption criteria (same intended use and same scientific fundamental technology as legally marketed devices of this type), a 510(k) and FDA clearance is not required before marketing the device in the US. (If the device exceeds the limitations to exemption, a 510(k) submission and clearance is required prior to marketing.) These devices are not, how-ever, exempt from other general controls. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA. The manufacturers can confirm the exempt status and any limitations that apply to their devices at the FDA Web site for medical devices: www. fda.gov/MedicalDevices/
For most Class II devices and some not exempt Class I devices, a 510(k) submission and clearance is required for marketing. A 510(k) is a premarket submission to the FDA that compares the subject device to one or more similar devices currently legally marketed in the US, to support their “substantial equivalence.” A legally marketed device(s) to which equivalence is drawn is known as a “predicate” device (see 21 CFR 807.92(a)(3)).
Due to the high risk associated with Class III devices, the FDA deter-mined that general and special controls alone are insufficient to ensure the safety and effectiveness of Class III devices. Therefore, these devices require a PMA (premarket approval) application to obtain marketing approval. PMA is the most stringent type of device marketing application required by the FDA. PMA approval is based on a determination by the FDA that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s). An applicant must receive FDA approval of its PMA application prior to marketing the device. An approved PMA is, in effect, a license granting the applicant (or owner) permission to market the device.
Investigation Device Exemption
For all Class III devices and some Class II devices, clinical performance data are required to be included in the regulatory market-ing submissions. An investigational device exemption (IDE) allows the investigational device to be shipped and used in a clinical study to collect safety and effectiveness data required to support an application to the FDA requesting clearance to market. The purpose of an IDE is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and, to that end, to maintain optimum freedom for scientific investigators in their pursuit of this purpose.
All clinical evaluations of investigational devices, unless exempt (eg, certain studies of lawfully marketed devices), must have an approved IDE before the study is initiated. Investigations covered under the IDE regulation are subject to differing levels of regulatory control, depending on the level of risk. The IDE regulation distinguishes between significant and nonsignificant risk device studies. The procedures for obtaining approval to begin the study differ accordingly.
An approved IDE permits a device to be shipped lawfully for the pur-pose of conducting investigations of the device without complying with the requirements that apply to devices in commercial distribution. In addition, while the device is under investigation, IDE sponsors are exempt from several other regulations.
US Food and Drug Administration. Device classification. FDA Web site. Retrieved from https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYour-Device/default.htm.
US Food and Drug Administration. Medical device innovation initiative white paper. FDA Web site. Retrieved from https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedical-ProductsandTobacco/CDRH/CDRHInnovation/ucm242067.htm.
US Food and Drug Administration. Overview of device regulation. FDA Web site. Retrieved from https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm.