FDA’s role in the ophthalmic
device evaluation process

I am an ophthalmologist and currently I work as a medical officer in the U.S. Food and Drug Administration Center for Devices and Radiological Health/Division of Ophthalmic and ENT Devices.

Like many of you, throughout my medical school and residency, I learned very little about FDA’s role. Thus, I can understand the general confusion and apprehension that some of you express at the thought of FDA’s involvement in ophthalmology.

A lot of practitioners’ comments received by the FDA reflect a lack of knowledge concerning what we do and how we do it.
Therefore, I feel that it is important for me to write this column for EyeWorld, focusing on the FDA’s role in the ophthalmic device evaluation process.

It is my goal to de-mystify the process.

In this introductory column, I will focus on the FDA’s overall organization, origins of its regulatory authority, and some basic regulatory requirements.

Organization of the FDA

The 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.

The agency is comprised of six centers — the Center for Devices and Radiological Health (CDRH), Center for Food Safety and Applied Nutrition (CFSAN), National Center for Toxicological Research (NCTR), Center for Veterinary Medicine (CVM), Center for Biologics Evaluation and Research (CBER), and Center for Drug Evaluation and Research (CDER).

Each center’s function is relatively clear from their names. The CDRH is responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the United States.

Before discussing regulation of devices, we need to define “device.” An instrument or machine is considered a “device” if it is in intended for use in the diagnosis of disease or in the cure, mitigation, treatment, or prevention of disease, 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 such as drugs.

There are thousands of types of medical devices, from heart pacemakers to contact lenses. The Office of Device Evaluation (ODE), one of the offices within CDRH, is responsible for reviewing requests to research or market all medical devices.

Requests specific to the research or marketing of ophthalmic devices are reviewed by the Division of Ophthalmic and ENT Devices, one of five divisions within the ODE.

Now that I explained where within FDA the review of ophthalmic devices occurs, the question that arises is when and how the FDA received this authority.

FDA origins

The FDA is one of the nation’s oldest consumer protection agencies. Congress laid the foundation for modern food and drug law when it passed the Food and Drugs Act of 1906.

This first nationwide consumer protection law made it illegal to distribute misbranded or adulterated foods, drinks, and drugs across state lines.
In 1937, a public health disaster tragically drove home the need for a stronger federal law. Sulfanilamide, the first “wonder drug” and a popular and effective treatment for diseases such as strep throat and gonorrhea, was formulated into an Elixir of Sulfanilamide and marketed for use in children.

But the liquid formulation contained a poison — the same chemical used in antifreeze — and it killed 107 people, most of them children. The earlier law did not require the drug’s manufacturer to test the formulation for safety before it was sold.

Congress corrected this weakness in the law the next year when it passed the Federal Food, Drug, and Cosmetic Act. This law, for the first time, required manufacturers to provide evidence of safety to the FDA before drugs could be marketed.

Amendments to the Act in 1962 added the requirement of demonstration of effectiveness to the condition of approval. The medical device amendment of 1976 extended these controls to devices. Thus, the FDA became responsible for ensuring that excimer lasers, endotamponades, and viscoelastics.

The basic regulatory requirements that all manufacturers of medical devices distributed in the U.S. must comply with are stipulated in the Federal Food, Drug, and Cosmetic Act. These general controls are:

• Establishment registration with the FDA;
• Medical device listing with the FDA;
• Quality System (QS) regulation;
• Labeling requirements; and
• Medical Device Reporting (MDR).

Classification of devices

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.

Regulatory control increases from Class I to Class III classification is primarily risk based. 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.

Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices.

Ophthalmic examples of Class I devices include the visual acuity chart, perimeter, 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 vitrectomy and phacoemulsification instruments and daily wear contact lenses.

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 which present a potential, unreasonable risk of illness or injury. Ophthalmic examples of Class III devices include intraocular lenses, excimer lasers, endotamponades, and viscoelastics.

The class to which a specific device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market.

In my next column, I will describe the various regulatory submissions necessary to study an investigational device and to get a new device to market. I also will address common problems in ophthalmic device trials that lead to inadvertent delays in the approval process and /or cause the device never to reach the U.S. market.

View Classification of Medical Devices

About the author

Malvina B. Eydelman, M.D. is an ophthalmologist. She is a medical officer in the U.S. Food and Drug Administration (FDA) /Center for Devices and Radiological Health / Division of Ophthalmic and ENT Devices.