Medical devices are regulated under the Medical Device Amendment Act of 1976. This act comes under the authority of the U.S. Food and Drug Administration. The FDA establishes standards for medical devices and ensures that the standards are met by equipment manufacturers. The FDA's Center for Devices and Radiological Health also oversees firms that repackage, relabel and/or import medical devices.
The FDA grades medical devices into classes 1, 2 and 3. This classification system defines the regulatory measures for a particular device. The regulatory control increases from Class 1 to Class 2, with Class 3 devices being considered high-risk devices that have the potential to cause significant illness or injury.
According to the FDA, there are seven basic regulatory requirements that medical device manufacturers must comply with.
Establishment Registration
It's required that all domestic and foreign manufacturers, as well as importers of medical devices, must register their establishments with the FDA. An establishment is defined as a place of business associated with the production and distribution of medical devices planned for use in the United States. Establishment registration must be completed once a year. The FDA collects an annual fee for this registration.
Medical Device Listing
The FDA mandates that all manufacturers must report the medical devices they make, in addition to their intended use and specific activities to be performed on a device. The following establishments are included in this measure:
• manufacturers
• contract manufacturers that commercially distribute the device
• contract sterilizers that commercially distribute the device
• repackagers and relabelers
• specification developers
• reprocessors' single-use devices
• remanufacturer
• manufacturers of accessories and components sold directly to the end user
• U.S. manufacturers of "export only" devices
Premarket Notification and Approval
Class 1, 2 and 3 medical devices must be demonstrated to be safe and effective before being marketed in the U.S. Once proof is submitted, the FDA evaluates the claim and provides clearance if deemed appropriate.
Investigational Device Exemption
In order to collect data on the safety and effectiveness of a medical device, the FDA allows an investigational device exemption (IDE). This permits manufacturers to use the device in clinical study and evaluation to provide evidence to support the Premarket Notification and Approval applications. Clinical study cannot commence without FDA approval of the IDE.
Quality System Regulation
Quality Systems Regulation involves good manufacturing practices for medical devices. This helps ensure that medical devices consistently meet the appropriate requirements. The FDA inspects facilities to verify compliance with their specified methods of designing, purchasing, manufacturing, packaging, storing, labeling, installing and servicing medical devices.
Labeling
Any labels that can be found on a device or on the packaging of a device, as well as any literature that accompanies the medical device, must comply with FDA standards. These regulations are detailed in Title 21 of the Code of Federal Regulations.
Medical Device Reporting
Device malfunctions, or injuries and deaths caused by a medical device, must be reported to the FDA. After a medical device has been cleared to be marketed in the U.S., the FDA retains the right to track and monitor it. This serves to detect problems and correct them in an efficient manner.
References
- FDA
- Fundamentals of Respiratory Care; Robert L. Wilkins, PhD. et al.; 2009
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