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Three Classifications of Medical Devices.

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Gigi Nguyen

Medical Device Industry- Winter 2019

Three Classifications of Medical Devices

All Medical Device sold in United States are regulated by the U.S Food and Drug Administration. FDA issue regulations that classify all devices in commercial distribution at that time. There are three regulatory control classifications – Class I, Class II, and Class III --. The classification assigned depend upon the degree of regulation necessary to provide reasonable assurance of their safety and effectiveness and depend upon the level of risk that is associated with the device. A medical device manufacturer must meet the class into which a device is placed determines the requirement prior to distributing product. According to section 513 (a) (1) of the FD &C Act (21 U.S.C. § 360c(a)(1)) in 21 CFR 862-892, the three device classes are defined as follows:

  • Class I: Class I medical devices are simple devices that have a low to moderate risk to the patient and user and require to comply with the lowest level of regulation control. Today, 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process. If a device falls into a generic category of exempted Class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, the manufacturer is required to register their establishment and list their generic product with FDA. Examples include enema kits, elastic bandages, manual stethoscopes, or bedpans.
  • Class II: lass II medical devices are simple and more complicated and slightly higher risk than class I devices. Class II require to comply with stringent regulatory controls to provide assurance of their effectiveness and safety. 43% of medical devices fall under this category. Most medical devices are considered Class II devices. Examples of Class II devices are powered wheelchairs, condom, or some pregnancy test kits.
  • Class III: Class III medical devices are most complex level devices and have a high risk to the patient and/or user. These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. They represent 10% of medical devices regulated by the FDA. Examples of Class III devices include implantable pacemakers or breast implants.

Oratect® Oral Fluid Drug Screen Device

The Oratect® Oral Fluid Drug Screen Device is class II device. It is an one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), Morphine (OP), and Phencyclidine (PC) in human oral fluid.

Illegal drug consumption contributes to many accidents, injuries and medical conditions. Screening individuals for drugs of abuse is an important method in identifying those who may cause harm to themselves and to others. It can be used at the Point-of-Care site.

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