Know All about Medical Devices

Center for Devices and Radiological Health (CDRH) under the United States federal Food and Drug Administration (FDA) is responsible for regulating firms/ companies who re- package, manufacture, re- label or /and import medical products and devices that are sold in the United States. Additionally, CDRH is responsible for regulating radiation emitting electronic products (non- medical and medical) such as x – ray systems, lasers, ultrasound equipments etc.

According to the CDRH, the information gathered from medical devices or products reveals that malfunctioned devices may be responsible for causing serious injury or even death. This data is contained in the following:

Manufacturer and User Facility Device Experience (MAUDE) database:

The MAUDE data consists of all user facility reports since 1991, manufacturer reports since August 1996, voluntary reports since June 1993 and distributor reports since 1993. Currently, the database consists of approximately 1.2 million reports.

Medical Device Reporting (MDR) database:

The MDR file consists of reports received under both the mandatory voluntary reports up to June 1993 and the Medical Device Reporting Program (MDR) from 1984 – 1996. Currently, this database contains more than 600, 00 reports.

All manufacturing devices or products that are imported or manufactured into the United States have to list with FDA. Following firms have to list their medical products or devices:

• Manufacture components or accessories sold directly to the end user
• Reprocess single-use devices.
• Repackage and re-label.
• Remanufacture.
• Develop specifications.
• Manufacture

The Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act determined three regulatory classes for medical products or devices. These three different classes are based on the extent of control mandatory to assure that the several types of products or devices are effective and safe. These classes include the following:

Class I:

These devices present minimum potential for risk to the user and are simpler in design as compared to the Class II or Class III devices. For example, elastic bandages or enema kits. Overall, about 47 percent of medical products or devices fall in this category and 95 these are exempted from the regulatory procedure.

Class II:

The majority of medical devices fall under this category of Class II devices. Some examples of Class 2 medical devises include pregnancy test kits and powered wheel chairs. In total, about 45 percent of medical products or devices fall under this category.

Class III

Generally, these devices support or sustain life are implanted or possess potential risk of injury or illness. Breast implants and pacemakers are few examples of Class III medical devices. Overall, 11 percent of medical products or devices fall under this category.

Exempt:

If a device belongs to the generic category of exempted Class 1 medical devices, a Premarket Notification (PMN) application and the Food and Drug Administration is not required before marketing the medical device or product in the United States. However, it is mandatory for manufacturer to list their generic products and establishment with FDA. Some examples of exempt devices include bedpans, stethoscopes and mercury thermometers.

Under Section 510(k) of the Food, Drug and Cosmetic Act medical device, manufacturers who register and notify the FDA of their intention to market a medical device, is called Premarket Notification (PMN) or 510(k). Under 510(k), it is important for a manufacturer to demonstrate to the FDA’S satisfaction that the medical device is safe and effective and is suitable for the market use. If FDA rules that the device is “substantially equivalent,” then the manufacturer can market the product.

Manufacturers of the medical device have to submit Premarket Approval (PMA) to the FDA if they want to market ant new medical product or device containing new materials or that is different in design from the medical devices already available in the market.

However, with all the safeguards and regulations, medical devices that may cause a serious injury or harm are available in the medical community. Regularly, FDA issues updates regarding withdrawn or recalled devices and warning notices.