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Medical Devices -- An Overview
The Federal Food and Drug Administration (FDA)`s Center for Devices and Radiological Health (CDRH) is responsible for regulating companies/firms who manufacture, repackage, re-label, and/or import medical devices that are sold in the U.S. In addition, the CDRH regulates radiation emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, etc.
The CDRH maintains information collected from device experience reports on medical devices which may have malfunctioned or caused a death or serious injury. This data is contained in the:
Medical Device Reporting (MDR) database - The MDR files contain reports received under both the mandatory Medical Device Reporting Program (MDR) from 1984 - 1996, and the voluntary reports up to June 1993. The database currently contains over 600,000 reports.
Manufacturer and User Facility Device Experience (MAUDE) database - The MAUDE data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996. The database currently contains about 1.2 million reports.
All medical devices that are manufactured and imported into the U.S. are required to be listed with the FDA. Firms that are required to list their devices are those that:
- Manufacture.
- Repackage and re-label.
- Develop specifications.
- Reprocess single-use devices.
- Remanufacture.
- Manufacture accessories and components sold directly to the end user.
The Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act established three regulatory classes for medical devices. The three classes are based on the degree of control necessary to assure the various types of devices are safe and effective. These classes are:
- Class I - These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. In total 47% medical devices fall under this category and 95% of these are exempt from the regulatory process.
- Class II - Most medical devices are considered Class II devices. Some examples of Class II devices include powered wheelchairs and some pregnancy test kits. In total, 43% of medical devices fall under this category.
- Class III - These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Some examples of Class III devices include implantable pacemakers and breast implants. In total 10% of medical devices fall under this category.
- Exempt - If a device falls into a generic category of exempted Class I devices, a Premarket Notification (PMN) application and FDA clearance is not required before marketing the medical device in the U.S. However, the manufacturer is required to register their establishment and list their generic product with FDA. Some examples of exempt devices are manual stethoscopes, mercury thermometers and bedpans.
Under Section 510(k) of the Food, Drug and Cosmetic Act medical device manufacturers who must register and notify the FDA of their intent to market a medical device. This is known as Premarket Notification (PMN) or 510(k). Under 510(k), before a manufacturer can market a medical device they must demonstrate to the FDA's satisfaction that it is substantially equivalent (as safe and effective) to a device that is already on the market. If FDA rules the device is "substantially equivalent," the manufacturer can market the device.
A primary safeguard in the way the FDA regulates medical devices is the requirement that manufacturers must submit a Premarket Approval (PMA) application if they wish to market any new products that contain new materials or differ in design from products already on the market.
A PMA submission must provide valid scientific evidence collected from human clinical trials showing the device is safe and effective for its intended use. If the device you are researching is life sustaining or presents a potential, unreasonable risk of illness or injury, you should search FDA's Premarket Approval (PMA) releasable database.
However, even with all these regulations and safeguards medical devices that ultimately cause harm are available in the medical community. The FDA issues regular updates regarding recalled devices and warning notices.
