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How Does Medical Device Compliance Work?

Medical Device Compliance
Medical Device Compliance

Medical devices are noted for saving lives. Of course, the use of such medical devices can often put patients a bit ill at ease when they consider their vulnerability to the performance and effectiveness of such devices. This is the reason the United States Food and Drug Administration (FDA) has been called upon to regulate and oversee the production of medical devices in the U.S.Because, without such regulation and stringent monitoring, medical device compliance would go unchecked, leaving an American public susceptible to devices that could rob them of the knowledge that they must seek help elsewhere, or even cause serious side effects, complications, and fatalities. Here’s more information on how the process of medical device compliance is carried out by the FDA.

Categorization of Medical Devices

Most medical devices must meet strict standards, both before and after they become available to the public. The FDA has devised a three-class system by which it categorizes and monitors medical devices for sale inAmerica. These categories are Class I, Class II, and ClassIII.

Class I

Class I includes medical devices that are not required to have approval by the FDA in order to be put on the marketplace. This may sound like it’s putting American consumers at risk from uncontrolled devices, but there is a very good reason that these devices are subject to very little regulatory control (called ‘general control’) by the FDA. They are classified such because they are not considered to be devices that are intended to help support or sustain life. They are also not considered to be significantly important in preventing damage to a person’s health. Class I devices include such products as bandages, tongue depressors, and gloves used to perform examinations.

Class II

Those products that are categorized as Class II medical devices are items noted to require ‘special control.’ This is because ‘general control’ is considered to be insufficient for assuring the safety and effectiveness of their use. Such regulatory oversights of the devices that need special control (along with general control) include manufacturer labeling, strict surveillance after such products are placed on the market for sale, and mandatory performance standards in order to ensure continued potency and effectiveness. Some examples of Class II medical devices include surgical drapes, powered wheelchairs, and acupuncture needles.

Class III

All medical devices that are placed in the ClassIIIcategory are done so because general and special controls are considered insufficient for ensuring their safety, effectiveness, and continued potency. These products are held to the highest of FDA standards, starting from the premarket approval stage, on through to the approval stage, through to the marketplace stage, and even after being made available. ClassIIImedical devices are those that support or sustain human health. These devices are also considered to play a significant role in preventing impairment to patients’ health. Additionally, ClassIIIdevices are considered to have the capability of presenting potential or unreasonable risk of injury or illness if they do not perform their functions as necessary. Some examples of devices that have a ClassIIIranking are implantable pacemakers, HIV diagnostic tests, and automated defibrillators.

Ensuring ongoing quality and effectiveness

Once medical devices are approved by the FDA for sale on the American marketplace, medical device manufacturers are required to set up certain quality assurance and control systems, with different levels of standards applied to each class of device. Though the FDA does rely on each medical device manufacturing company to set up its own system in order to be in proper medical device compliance, it is a well-known fact that the government watches all such devices closely to ensure that they do not cause illness, injury, or death. When such occurrences arise, companies are required to file reports regarding the types of problems involved, and they must do so within 30 days.

With the rise of the information age, as well as the number of lawsuits occurring in the country today, it is vital that all medical device manufacturers closely guard and analyze all the medical devices they produce. The FDA has set up a regulatory system that is unmatched throughout the world, ensuring that all such devices meet the strictest of standards in order to ensure patient safety and device performance. Without such medical device compliance, the millions of patients who depend on such devices would be left vulnerable to potential serious complications and even fatalities from the very devices they entrust with their health and their lives.

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