Market Authorization of In-vitro Diagnostic Devices in
USA
Definition of
In-vitro Diagnostic Devices (IVDs):
According to USFDA, in-vitro diagnostic (IVD) products are those reagents,
instruments, and systems intended for use in diagnosis of disease or other
conditions, including a determination of the state of health, in order to cure,
mitigate, treat, or prevent disease or its sequelae. Such products are intended
for use in the collection, preparation, and examination of specimens taken from
the human body [1].
Classification of IVDs:
|
Class I (Low Risk) |
Class II (Medium Risk) |
Class III (High Risk) |
|
Class I medical devices present the lowest potential for harm and are simpler in design than Class II or Class III medical devices. Class I medical devices are not intended to be: · For use in supporting or sustaining life; · Of importance in preventing impairment to human life; and · May not present a potential unreasonable risk of illness or injury. Examples of Class I medical devices include. Sample List of Class I Devices (Accessed on January 2, 2013) from USFDA Product Classification Database. |
Class II medical devices pose a moderate risk to patients, and may include new devices for which information or special controls are available to reduce or mitigate risk. Class II medical devices are defined as devices “which cannot be classified as Class I because the general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness of the device”. Examples of Class II medical devices include sutures, inflatable blood pressure cuffs, powered wheelchairs, infusion pumps and surgical drapes. Sample List of Class II Devices (Accessed on January 2, 2013) from USFDA Product Classification Database. Note: CBER regulates HIV test kits used to screen donor blood,
blood components and cellular products, and to diagnose, treat and monitor
persons with HIV and AIDs [2-4]. |
Class III medical devices pose a moderate risk to patients, and may include new devices for which information or special controls are available to reduce or mitigate risk. Class III medical devices are defined as devices that are life supporting or life sustaining, and devices which present a high or potentially unreasonable risk of illness or injury to a patient. Few examples of class III medical devices include drug-eluting coronary stents, cardiac ablation catheters, artificial hearts, breast implants, replacement heart valves and implanted cerebellar stimulators. Sample List of Class III Devices (Accessed on January 2, 2013) from USFDA Product Classification Database. |
Regulatory Pathway
for IVDs:
References:
[4] CBER
PMA Process