FDA Medical Device Regulations: What You Should Know

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In the United States, the U.S. Food and Drug Administration (FDA) regulates the production and sale of medical devices. The FDA releases rules regarding classification, registration, premarket approval, product labeling requirements, and quality controls for medical devices.

The FDA regulations apply to devices manufactured in the U.S. as well as imported medical devices. The Center for Devices and Radiological Health (CDRH), a branch of the FDA, oversees implementing regulations for the production and sale of medical devices in the U.S. as well as the safety and performance of these devices.

Congress passed the Food, Drug, and Cosmetics Act (FDCA) in 1938. The FDCA gives the FDA the authority to enact regulations impacting the production and sale of medical devices in the U.S.

The FDA maintains a classification system that categorizes medical devices into three tiers: Class I, Class II, and Class III. The classification level corresponds to the level of risk. Class I devices are the least regulated, while Class III devices are subject to the highest level of controls to ensure device safety and effectiveness.

Class I Medical Devices

FDA Class I medical devices are the most innocuous and have the least potential to cause harm. As a result, Class I medical devices are only subject to general controls. This means they are often exempt from premarket notification requirements and good manufacturing practice requirements.

Some examples of these low-risk devices include toothpaste, dental floss, nonelectric wheelchairs, and bandages. Many Class I devices are everyday items that are unlikely to cause serious consequences in the event of a malfunction.

Class I FDA Devices
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Class II Medical Devices

Class II medical devices are intermediate risk. They require special controls in addition to general controls. Such special controls include performance standards and post-market surveillance. The majority of medical devices are Class II medical devices. Examples include powered wheelchairs and certain pregnancy test kits.

Class III Medical Devices

Class III medical devices are the highest risk. They require premarket approval. This means that the FDA must approve them before a manufacturer may market or sell them. Class III medical devices are often those deemed to be of substantial importance in sustaining human life or preventing impairment of health. Examples of Class III devices include implantable pacemakers, cochlear implants, and defibrillators.

FDA Medical Device Good Manufacturing Practices

The FDA’s good manufacturing practice requirements fall within the agency’s Quality System Regulation (QSR). Manufacturers of medical devices must follow the QSR’s framework to ensure product quality control. The FDA’s good manufacturing practices set forth specific procedures for designing and manufacturing devices intended for human use.

Labeling Requirements for FDA Medical Devices

To avoid misleading patients, the FDA imposes strict guidelines for the packaging and labeling of medical devices. Every medical device must disclose the following information:

  • The manufacturer’s name and business location
  • The dosage quantity
  • The frequency and duration of use
  • When to use the device
  • Directions for how to administer or apply the device
  • Any preparation steps necessary for using the device
  • The device’s intended use

There are additional specific requirements for certain medical device categories. For instance, hearing aids must follow unique labeling requirements.

In order to protect patient safety, the FDA especially focuses on the prevention of misbranding. False or misleading labeling on the medical device itself or the advertising materials relating to the device can lead to manufacturer liability. When claims arise about misleading advertising or mislabeling, the FDA typically shares jurisdiction with the Federal Trade Commission (FTC).

510(k) Premarket Notification

In order to commercially distribute certain medical devices, manufacturers must submit a 510(k) premarket notification to the FDA. This procedure shows a device is marketed as safe and effective. A 510(k) premarket submission demonstrates “substantial equivalence.” This means that a device is substantially equivalent to a medical device already legally marketed in the U.S.

This is mandatory for medical devices for first-time commercial use. A 510(k) premarket notification is also required for devices already in commercial distribution if a manufacturer significantly modifies their design, components, or intended use.

Premarket Approval Application

To market Class III medical devices, manufacturers must submit a Premarket Approval Application (PMA) and receive FDA approval. The PMA process is significantly more intensive that the 510(k) premarket submission process. Due to the higher risk nature of Class III medical devices, the business must provide clinical data and scientific evidence of their safety and effectiveness.

FDA Incident Reports: Requirements for Manufacturers, Importers, and Medical Facilities

Medical device manufacturers are subject to several mandatory FDA reporting requirements. They must file a report with the FDA if they are aware a device they market has been linked to serious injury or death. Similarly, medical device importers must file a report with the FDA if they learn their device may have contributed to serious injury or death. In addition, when medical facilities like hospitals and nursing homes learn devices they use may have contributed to serious harm, they must file a report with the FDA and send a copy to the device manufacturer.

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