Overview of Device Regulation in Clinical Trials

4. December 2009 by rahul.

A medical device is a product which is 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. Examples: include tongue depressors, medical thermometers, blood sugar meters, and X-ray machines.

Classification of Medical Devices
The regulatory authorities in recognize different classes of medical devices, based on their design complexity, their use characteristics, and their potential for harm if misused. Approximately 1,700 types of medical devices are regulated by FDA.Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.
The three classes and the requirements which apply to them are:
 Class I - General Controls
 Class II - Special Controls
 Class III - Premarket Approval

Class I - General Controls: Class I devices are subject to the least regulatory control as present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples: elastic bandages, examination gloves, and hand-held surgical instruments.

Class II - Special Controls: Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness.. Examples: powered wheelchairs, infusion pumps, and surgical drapes

Class III - Premarket Approval: Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Premarket approval is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Examples: replacement heart valves, silicone gel-filled breast implants, and implanted cerebella stimulators.

The basic regulatory requirements that manufacturers of medical devices must comply with :

1. Establishment registration 21 CFR Part 807: Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA.

2. 2.Premarket Notification 510 (k)- 21 CFR Part 807 :A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device. Most Class I devices are exempt from the premarket notification and/or good manufacturing practices regulation.

3. Premarket Approval (PMA) - 21 CFR Part 814: Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

4. Investigational Device Exemption (IDE) - 21CFR Part 812: An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification 510(k) submission to FDA.

5. Good Manufacturing Practices (GMP) - 21 CFR Part 820: GMP includes requirements related to the methods used in: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices.

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