Market Authorization of Medical Devices in USA
Definition of Medical
Devices:
According
to USFDA, a medical device is an instrument, apparatus,
implement, machine, contrivance, implant, in vitro reagent, or other similar or
related article, including any component, part, or accessory, which is:
i.
recognized in the
official National Formulary, or the United States Pharmacopeia, or any
supplement
to them; or
ii.
intended for use in the
diagnosis of disease or other conditions, or in the cure, mitigation,
treatment,
or prevention of disease, in man or other animals; or
iii. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes [1].
Classification of
Medical Devices (Risk Based):
|
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 medical devices
involved in the collection, processing, testing, manufacture and
administration of licensed blood, blood components and cellular products
[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 Procedure
for Medical Devices:
References:
[4] CBER PMA Process