REGULATION OF MEDICAL DEVICES INNOVATION TUĞÇE YAŞAR

MEDICAL DEVICE DEFINITION A medical device is a apparatus,implement,machine,contrivance, implant,in vitro reagent or similar article including any component,part,accessory which is, -intended for use in the diagnosis of disease or conditions or in the cure,treatment and prevention of disease in human. -intended to affect structure or any function of human.

MEDICAL DEVICE Device definition excludes products that achieve its primary intended purposes through chemical action on the body of human Are dependent upon being metabolized for the achievement of its intended purposes. Medical devices range from simple devices such as medical thermometers to advanced devices such as medical robots,cardiac pacemakers

REGULATION OF MEDICAL DEVICES The regulatory aspects of medical devices differ from country to country. United States,Japan,European Union markets classify all medical devices according to risk. In the United States,medical devices are regulated by FDA,and devices are classified 3tiered system.

REGULATION OF MEDICAL DEVICES The Food And Drug Administration(FDA) is responsible for protecting public health by assuring the safety and effectiveness of variety of medical products,including medical devices.

CLASSIFICATION OF MEDICAL DEVICES Based on the risk(low,moderate,high) to patient posed by device. CLASS I DEVICES: General controls are sufficient to provide reasonable assurance of the safety and effectiveness -Examples:elastic bandages,examination gloves,

It presents a low risk of illness or injury to patients

GENERAL CONTROL Prohibitions against misbranded devices Premarket notification 510(k)requirements Good manufacturing practices Record keeping Listing of device types Registration of manufacturing facilities

CLASSIFICATION OF MEDICAL DEVICES CLASS II Devices :General controls alone are insufficient to assure safety and effectiveness. - Examples:Powered wheelchairs,surgical drapes

It pose moderate risk to patient

SPECIAL CONTROL Performance standards (voluntary national or international standards,recognized by rulemaking) Tracking requirements Design control Development of guidelines Recommendations and other actions

CLASSIFICATION OF MEDICAL DEVICES CLASS III DEVICES : Insufficient information exists to determine that general and special controls are sufficient to provide reasonable assurance of the safety effectiveness. -Examples:Life supporting,present unreasonable risk of illness or injury

CLASS III

CLASSIFICATION OF MEDICAL DEVICES

REGULATION ASPECTS OF MEDICAL DEVICES Medical devices are regulated by different regulatory structures and different guidelines are followed in different countries to determine safety and efficient of medical devices. The medical devices regulation based on risk. Device classification determines the type of regulatory requirements that a manufacturer must follow.

REGULATORY REQUIREMENTS General Controls :the minimum regulations that apply to all FDA regulated medical devices,include five elements. Establishment Registration:such as manufactures,distributors,repackagers,foreign firms. Device Listing:listing with FDA of all devices to be market.

REGULATORY REQUIREMENTS Good Manufacturing Practices(GMP):manufacturing of devices in accordance with the Quality System Regulations. Labeling:labeling of devices or in vitro diagnostic products. Premarket Notification:submission to FDA of a premarket notification 510(k)

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