12/8/2015
`
`Regulatory Controls
`
`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`Regulatory Controls
`
`Introduction
`General Controls
`Special Controls
`Premarket Approval (PMA)
`
`Introduction
`Federal law (Federal Food, Drug, and Cosmetic Act, section 513), established the risk-based device
`classification system for medical devices. Each device is assigned to one of three regulatory
`classes: Class I, Class II or Class III, based on the level of control necessary to provide reasonable
`assurance of its safety and effectiveness. For information related to device classification, please
`refer to “Classify Your Medical Device
`(/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm2005371.
`htm).”
`
`As device class increases from Class I, to Class II to Class III, the regulatory controls also increase,
`with Class I devices subject to the least regulatory control, and Class III devices subject to the most
`stringent regulatory control.
`The regulatory controls for each device class include:
`
`Class I (low to moderate risk): general controls
`Class II (moderate to high risk): general controls and Special Controls
`Class III (high risk): general controls and Premarket Approval (PMA)
`
`General Controls
`
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm2005378.htm
`
`1/4
`
`Ex. 2029-0001
`
`
`
`Regulatory Controls
`
`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`Regulatory Controls
`
`Introduction
`General Controls
`Special Controls
`Premarket Approval (PMA)
`
`Introduction
`Federal law (Federal Food, Drug, and Cosmetic Act, section 513), established the risk-based device
`classification system for medical devices. Each device is assigned to one of three regulatory
`classes: Class I, Class II or Class III, based on the level of control necessary to provide reasonable
`assurance of its safety and effectiveness. For information related to device classification, please
`refer to “Classify Your Medical Device
`(/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm2005371.
`htm).”
`
`As device class increases from Class I, to Class II to Class III, the regulatory controls also increase,
`with Class I devices subject to the least regulatory control, and Class III devices subject to the most
`stringent regulatory control.
`The regulatory controls for each device class include:
`
`Class I (low to moderate risk): general controls
`Class II (moderate to high risk): general controls and Special Controls
`Class III (high risk): general controls and Premarket Approval (PMA)
`
`General Controls
`
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm2005378.htm
`
`1/4
`
`Ex. 2029-0001
`
`
`
`12/8/2015
`
`Regulatory Controls
`
`General controls are regulatory requirements authorized by the FD&C Act, under sections 501, 502,
`510, 516, 518, 519, and 520. General controls apply to all medical devices, unless exempted by
`regulations. If a device is exempted from one of the general controls, such exemption is stated in
`the classification regulation for that device.
`
`For example, the classification regulation for manual tooth brush, 21 CFR 872.6855, states the
`general controls from which tooth brushes are exempted and certain limitations on the exemptions.
`
`General controls are described in the following sections of the FD&C Act:
`
`501: Adulterated devices
`502: Misbranded devices
`510: Registration of producers of devices
`Establishment registration and device listing
`Premarket Notification (510k)
`Reprocessed single-use devices
`516: Banned devices
`518: Notifications and other remedies
`Notification
`Repair
`Replacement
`Refund
`Reimbursement
`Mandatory recall
`519: Records and reports on devices
`Adverse event report
`Device tracking
`Unique device identification system
`Reports of removals and corrections
`520: General provisions respecting control of devices intended for human use
`Custom device
`Restricted device
`
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm2005378.htm
`
`2/4
`
`Ex. 2029-0002
`
`
`
`12/8/2015
`
`Regulatory Controls
`
`Good manufacturing practice requirements
`Exemptions for devices for investigational use
`Transitional provisions for devices considered as new drugs
`Humanitarian device exemption
`
`Special Controls
`Special controls are regulatory requirements for class II devices. FDA classifies into class II devices
`for which general controls alone are insufficient to provide reasonable assurance of the safety and
`effectiveness of the device, and for which there is sufficient information to establish special controls
`to provide such assurance.
`Special controls are usually device-specific and include:
`
`Performance standards
`Postmarket surveillance
`Patient registries
`Special labeling requirements
`Premarket data requirements
`Guidelines
`
`Premarket Approval (PMA)
`Under federal law, class III devices are subject to approval of a Premarket Approval Application
`(PMA).
`(/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAAppr
`ovals/ucm2000000.htm)
`
`Devices that are not within a type marketed before the date of the Medical Device Amendments of
`1976 – referred to preamendments devices – are classified into class III automatically under federal
`law.. In addition, the FDA classifies into class III devices intended to be used in supporting or
`sustaining human life or preventing impairment of human health, or that may present a potential
`
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm2005378.htm
`
`3/4
`
`Ex. 2029-0003
`
`
`
`12/8/2015
`
`Regulatory Controls
`
`unreasonable risk of illness or injury for which general controls and special controls are insufficient
`to provide reasonable assurance of the safety and effectiveness of a device, or for which there is
`insufficient information to make such a determination.
`
`For more information on PMA, please read the following sections:
`
`FD&C Act section 513 and section 515
`(/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/ucm200564
`0.htm)
`21CFR Part 814 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?
`CFRPart=814)
`Device Advice on PMA
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSub
`missions/PremarketApprovalPMA/ucm2007514.htm)
`
`More in Regulatory Controls (Medical Devices)
`(/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm)
`
`General Controls for Medical Devices
`(/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm055910.htm)
`
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm2005378.htm
`
`4/4
`
`Ex. 2029-0004
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