REGULATION OF MEDICAL DEVICES INNOVATION

TUĞÇE YAŞAR290707001

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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