Overview of FDA Regulatory Requirements for Medical Devices, by Mark Prinz, Registrar Corp

The United States government utilises a complex array of laws and regulations to oversee the marketing of medical devices in the USA. Beginning in 1938, then President Franklin D Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (FD&C Act), which remains the principal law regulating all medical devices today. This Act, detailed in the United States Code (USC), directs the US Food and Drug Administration (FDA) to promulgate regulations to enforce the law. As these regulations are written, they are added into Title 21 of the Code of Federal Regulations (CFR). Medical device regulations in particular occupy 21 CFR Sections 800-898.

There are four major steps that a device manufacturer must take in order to comply with the regulations set forth by the FDA.

Step 1

The first step is to determine if the product actually meets the definition of a medical device found in the FD&C Act. Medical devices are defined as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory, which is intended for use in the diagnosis, treatment, mitigation, cure, or prevention of disease, or intended to affect the structure or any function of the body of man or other animals.

Examples of medical devices include a wide range of products, from cotton swabs to MRI machines. Crucially, a medical device must not achieve any of its primary intended purposes through chemical action within or on the body, and cannot be dependent upon being metabolised for the achievement of any of its primary intended uses. Inclusion of any chemical or metabolic action may cause the device to be classified as a combination product, consisting of both a medical device and a drug.

Step 2

Once a product has been verified to fit the statutory definition of a medical device, the next step is to determine the class of device under which the product will be regulated. The FDA separates devices into three classification levels based on the potential risk to human health, and imposes stricter requirements on higher risk devices. There is also a separate group of devices known as “preamendment devices,” which were legally marketed in the US prior to the 1976 Medical Devices Amendment Act and have remained substantially unchanged.

Class I devices, such as elastic bandages and examination gloves, are subject to “general controls,” consisting of establishment registration, device listing, good manufacturing practices (GMPs), labeling, and submission of a Premarket Notification [510(k)] prior to marketing the product in the US. Over 800 generic types of Class I devices, however, have been exempted from the 510(k) requirement. The 510(k) is named after the reference to the section of the Food, Drug and Cosmetic act which defines the regulation for introducing a device into interstate commerce..

General controls alone are insufficient to assure safety and effectiveness of Class II devices, such as powered wheelchairs and infusion pumps. Accordingly, such devices are also subject to “special controls,” which may include special labeling requirements, mandatory performance standards, and postmarket surveillance. Some Class II devices, however, have also been exempted from the 510(k) requirement.

For Class III devices, there is insufficient information to assure safety and effectiveness solely through general and special controls. Such 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. To market a Class III device, a firm must obtain Premarket Approval (PMA) from the FDA through the submission of scientific, regulatory, and clinical data affirming the safety and effectiveness of the product.

When a manufacturer is unsure as to how the FDA would classify a device, section 513(g) of the FD&C Act allows any person to submit a written request for classification to the FDA. Within 60 days of the receipt of the request, the FDA will respond with whether or not the product can be classified as a medical device, what the classification is, and what requirements apply to the product, including whether or not the product is exempt from premarket notification requirements.

Step 3

If it is determined that a product is subject to premarket requirements, then the next major step to marketing the device is the development of data or information necessary to submit a marketing application to the FDA to obtain clearance or approval of the product. Depending on the classification of the device, this may require a 510(k) or PMA application.

The 510(k) notification is intended to demonstrate that the device is substantially equivalent to a legally marketed device, or predicate device, and is therefore as safe and effective as the predicate device. If the FDA accepts that the product is substantially equivalent to a legal predicate device, it will grant marketing clearance for the product.

The 510(k) process does not, however, lead to product “approval.” In order to obtain approval of a device, one must complete a PMA application, which as stated previously, requires the submission of scientific, regulatory, and clinical documentation to assure the device is safe and effective for its intended use(s) or indication(s) for use. Devices that are required to submit PMA applications may not legally market the device until obtaining FDA approval.

Step 4

The owners or operators of establishments or facilities that are involved in the production and distribution of the device are required to register annually with the FDA, and most are also required to list the devices that are produced or processed there and the activities that are performed on those devices.

When an establishment registers with the FDA for the first time, it must do so within 30 days of beginning its device operations. The registration must then be renewed every year between October 1 and December 31. With the initial registration, the FDA will assign an Owner/Operator Number prior to issuing an Establishment Registration Number. An owner or operator is assigned only one Owner/Operator Number, but may have multiple establishments, each with its own Establishment Registration Number.

For the purpose of registration, an establishment is any place of business under one management at one physical location at which a device is manufactured, assembled, or otherwise processed for commercial distribution.

Foreign establishments must also declare a US agent in its registration. The agent must reside or maintain a place of business in the US and assists the FDA in communicating with the foreign establishment.

Summary

In addition to the steps above, certain devices may be subject to additional FDA requirements. Many devices, for example, have specific labeling requirements. The design and manufacture of medical devices must comply with GMPs set forth in the Quality System Regulations (QSR), a quality assurance system similar to ISO13485. In addition, once a device enters the US market, any significant adverse events, such as deaths, serious injuries, or malfunctions of the device, must be reported to the FDA. Finally, any medical device that incorporates electronic components may also subject to Radiation Emitting Device (RED) regulations, which may have separate labeling and reporting requirements.

Registrar Corp has the expertise to assist companies in complying with FDA medical device regulations, including US Agent services, establishment registrations, labeling, and 510(k) administrative reviews, as well as RED requirements for electronic devices. With 19 global offices, Registrar Corp’s team of multilingual regulatory specialists is available to assist you. For immediate assistance with, phone Registrar Corp at +1-757-224-0177, or receive Live Help at www.registrarcorp.com.