FDA Medical Device Regulations – What You Need to Know
The U.S. Food and Drug Administration (FDA) regulate the sale and production of medical devices. FDA issues rules about classification, registration, approvals, product labelling requirements, and quality control for medical devices.
FDA regulations apply to both imported and manufactured medical devices. A branch of the FDA, the Center for Devices and Radiological Health, oversees the implementation of regulations for the sale and production of medical devices in the U.S. and safety and performance.
1938 saw the passage of the Food, Drug, and Cosmetics Act by Congress. The FDA has the power to enact regulations that affect the sale and production of medical devices in the United States under the FDCA.
The FDA maintains a classification system that categorizes medical devices into classes I, II, and III. The classification level determines the level of risk. Devices classified as Class I are not subject to regulation, but devices classified as Class III are subject to stricter controls to ensure safety and effectiveness.
Class I Medical Devices
FDA Class I medical devices, which are FDA-approved, are the least dangerous and most likely to cause injury. Because they are not subject to general controls, Class I medical devices do not have to be subject to any special regulations. Therefore, they are often exempted from the premarket notification requirements and reasonable manufacturing practice requirements.
These devices are categorized as low-risk and include nonelectric wheelchairs, bandages, toothpaste, and dental floss. Many Class I devices are common everyday items that are unlikely cause any severe problems in the event of a malfunction.
Class 2 Medical Devices
Class II medical devices pose an intermediate risk. These devices require additional controls to the general controls. These unique controls include post-market surveillance and performance standards. Most medical devices are classified as Class II. Some examples include powered wheelchairs and specific pregnancy test kits.
Class 3 Medical Devices
The highest risk medical devices of Class III pose the most significant risk. They need premarket approval. The FDA must approve them before they can be sold or marketed. These medical devices, often classified as Class III, are of significant importance in maintaining human life or preventing health impairments. Implantable pacemakers, cochlear implants, and defibrillators are examples of Class III medical devices.
FDA Medical Device Good Manufacturing Practices
The FDA’s requirements for good manufacturing practices fall under the QSR. Medical device manufacturers must adhere to the QSR framework to ensure quality control. The FDA sets out specific procedures for manufacturing devices for human consumption.
Labeling requirements for FDA Medical Devices
The FDA has strict guidelines regarding the packaging and labeling of medical devices to avoid misleading patients. The following information must be disclosed on every medical device:
- The name of the manufacturer and the business address
- The dosage quantity
- Use frequency and duration
- When should the device be used?
- Instructions on how to use the device
- Preparation steps for the use of the device
- The intended purpose of the device
Specific medical devices have additional requirements. Hearing aids, for example, must adhere to specific labeling requirements.
The FDA focuses mainly on preventing misbranding to ensure patient safety. Manufacturer liability can be triggered by misleading or false labeling of medical devices or advertising materials. The FDA shares jurisdiction with FTC regarding mislabeling or misleading advertising.
510 (k) Premarket Notification
To commercially distribute certain medical products, manufacturers must submit a premarket notification. This is how a device can be marketed as safe or effective. A 510(k) premarket submission demonstrates “substantial Equivalence,” which means that the device is substantially equivalent to a medical device legally marketed in the U.S.
This requirement is required for medical devices used for the first time in commercial distribution. Devices already in commercial distribution must also be notified by 510(k) if the manufacturer makes significant changes to their design, components, or intended use.
Premarket Approval Form
Manufacturers must submit a Premarket Application (PMA) to market Class III medical devices. FDA approval is required. The PMA submission process is more complex than the 510(k) premarket submission process. Because Class III medical devices are riskier, businesses must provide scientific evidence and clinical data to support their safety and effectiveness.
FDA Incident reports: Requirements for Manufacturers, Importers, and Medical Facilities
FDA has several reporting requirements for medical device manufacturers. If they become aware that a device they sell has caused severe injury or death, they must file a report to the FDA. If they discover that their medical device contributed to severe injury or death, importers of medical devices must also file a report to the FDA. Additionally, suppose a device they used has caused severe injury or death. In that case, hospitals and nursing homes must file a report with FDA and send a copy of the report to the manufacturer.
