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 .
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.
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.
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.
Regulatory Procedure for Medical Devices:
 CBER PMA Process