regulation of medical devices innovation tuĞÇe yaŞar 290707001
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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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