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`Regulatory Controls (Medical Devices) > General Controls for Medical Devices
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`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`General Controls for Medical
`Devices
`
`Introduction
`Application of The Provisions of General Controls
`Adulteration
`Misbranding
`False or Misleading Labeling
`Establishment Registration Requirements
`Device Listing Requirements
`Premarket Notification Requirements
`Banned Devices
`Notification and Other Remedies
`Records and Reports On Devices
`Restricted Devices
`Quality System Regulation, Good Manufacturing Practices
`
`Introduction
`General Controls are the basic provisions (authorities) of the May 28, 1976 Medical Device
`Amendments (hereafter referred to as the Amendments) to the Food, Drug and Cosmetic Act, that
`provide the FDA with the means of regulating devices to ensure their safety and effectiveness. The
`General Controls in the Amendments apply to all medical devices. They include provisions that
`relate to adulteration; misbranding; device registration and listing; premarket notification; banned
`devices; notification, including repair, replacement, or refund; records and reports; restricted
`devices; and good manufacturing practices.
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`Application of The Provisions of General Controls
`Devices are classified according to the degree of difficulty in assuring their safety and effectiveness.
`Class I, which is synonymous with General Controls, is the least stringent of the three device
`classes provided in the Amendments. Before placing a device in Class I, the FDA must first
`determine that there is sufficient information available to support such a classification decision.
`Second, the FDA must decide that the General Controls are sufficient to provide reasonable
`assurance of the device's safety and effectiveness. Class I devices are not subject to the restrictions
`of Class II - Special Controls or Class III - Premarket Approval. In addition, Class I devices are not
`intended for use in supporting or sustaining life or to be of substantial importance in preventing
`impairment to human health, and they may not present a potential unreasonable risk of illness or
`injury
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`Unless otherwise exempted, the General Controls provisions of the Amendments are applicable to
`all devices regardless of their classification status.
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`KEY POINTS
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`General Controls are the basic authorities of the Medical Device Amendments that provide the
`FDA with the means of regulating devices to ensure their safety and effectiveness.
`General Controls apply to all three classes of medical devices; however, they are the only level of
`controls that apply to Class I devices.
`Class I devices are not intended to be:
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`1. For use in supporting or sustaining life;
`2. Of importance in preventing impairment to human life; and may not
`3. Present a potential unreasonable risk of illness or injury
`General Controls include the provisions of the Act pertaining to:
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`1. Adulteration;
`2. Misbranding;
`3. Device registration and listing;
`4. Premarket notification;
`5. Banned devices;
`6. Notification and repair, replacement, and refund;
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`7. Records and reports;
`8. Restricted devices; and
`9. Good Manufacturing Practices.
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`Adulteration
`Medical devices are subject to the adulteration provisions of the FD&C Act under Section 501. The
`first two provisions of Section 501 define adulteration for most cases. A device is held to be
`adulterated if it includes any filthy, putrid, or decomposed substance, or if it is prepared, packed, or
`held under unsanitary conditions. The FD&C Act further states that a device is held to be
`adulterated if:
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`Its container is composed, in whole or part, of any poisonous or deleterious substance;
`It contains, for the purposes of coloring only, an unsafe color additive; and
`Its strength differs from, or its purity or quality falls below, that which it claims to represent.
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`When the Medical Device Amendments were added to the FD&C Act, certain conforming laws,
`applying specifically to medical devices, were added to Section 501. These provisions relate directly
`to other portions of the Amendments, granting the FDA authority to control performance standards;
`compliance with premarket approval applications and product development protocol requirements;
`banning; good manufacturing practices; and investigational device exemptions. These sections
`state that a device will also be considered adulterated if:
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`It is subject to a performance standard and does not comply with all the requirements of the
`standard;
`It is a Class III device and fails to conform to the requirements for an approved premarket
`approval application or a notice of completion of a product development protocol;
`It is a banned device;
`It is in violation of good manufacturing practice requirements; or
`It fails to comply with an Investigational Device Exemption (IDE).
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`Misbranding
`The misbranding provisions of the FD&C Act in Section 502 cover various aspects of drug and
`device labeling requirements. Many of the provisions apply to drugs and devices both; however,
`there are also specific misbranding provisions that apply to only drugs or only devices. The
`misbranding provisions that apply to both drugs and devices are listed in the following:
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`Drugs and Device Misbranding Provisions
`A drug or device is deemed to be misbranded if:
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`Its labeling is false and misleading.
`Its packaging does not bear a label containing:
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`1. the name of the place of business of the manufacturer, packer, or distributor, and
`2. an accurate statement of the quantity of contents in terms of weight, measure, or numerical
`count.
`Reasonable variations and exemptions for small packages may be permitted.
`Any word, statement, or other required information is not prominently placed on the labeling or
`not clearly stated so as to be read and understood by the ordinary individual under customary
`conditions of purchase and use.
`It is for use by man and contains any quantity of a narcotic or habit forming substance, unless its
`label bears the name and quantity or proportion of the substance or derivative and the statement
`"Warning - may be habit forming."
`Its label does not bear adequate directions for use. The label must include warnings against use
`in certain pathological conditions or by children where its use may be dangerous to health, or
`against unsafe dosage or methods or duration of administration or application. Adequate
`directions and warnings must be present when it is necessary to protect the health of the user.
`Exemptions to this provision may be obtained. The phrase "adequate directions for use" pertains
`to over-the-counter drugs and device.
`It is dangerous to health when used in the dosage or manner, or with the frequency or duration
`prescribed, recommended, or suggested in the labeling.
`It does not comply with the color additive provisions listed under Section 706 of the FD&C Act.
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`Device Misbranding Provisions Added by the Amendments
`The Amendments added new authority relating to the misbranding of medical devices. These new
`provisions state that a device is misbranded if:
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`The device's established name (if it has one) or its name in an official compendium, or any
`common or usual name, is not prominently printed in type at least half as large as that used for
`any proprietary name or designation. Exemptions from this provision may be granted.
`A restricted device offered for sale in any State uses false or misleading advertising, or is sold,
`distributed, or used in violation of restricted device regulations under Section 820(e) of the FD&C
`Act.
`A restricted device manufacturer, packer, or distributor fails to include in all advertisements or
`other descriptive materials:
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`1. a true statement of the device's established name, prominently printed, and
`2. a brief statement of the intended uses of the devices and relevant warnings, precautions,
`side effects, and contradictions.
`The device commercially distributed without FDA concurrence on a Section 510(k) submission.
`The device is subject to a performance standard and it does not bear the labeling prescribed in
`that standard.
`There is a failure or refusal to comply with any requirement prescribed under section 518
`(Notification and Other Remedies); to furnish any material or information required by or under
`Section 518; or to furnish any material or information requested by or under Section 519
`(Records and Reports on Devices).
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`False or Misleading Labeling
`The FD&C Act states that a drug or device is misbranded "if its labeling is false or misleading in any
`particular." "Labeling" includes the label and any other written, printed, or graphic material that
`accompanies a device and any of its wrappers or containers. Operating and servicing instructions
`are also regarded as part of the labeling. The labeling must bear adequate directions for use and
`any warnings needed to ensure the safe and effectiveness use of the device
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`Medical Device Labeling Information
`(/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/default.htm)
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`Establishment Registration Requirements
`The Amendments require in Section 510 that manufacturers and other specified processors of
`devices register their establishments with the FDA and provide to the FDA a list of all devices
`manufactured in any establishment which they operate. Repackers, relabelers, and importers are
`also required to register with the FDA.
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`Device Listing Requirements
`Section 510 also states that medical device manufacturers must submit to the FDA a list of all
`devices they produce or process. This listing is maintained by the FDA.
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`Premarket Notification Requirements
`Section 510(k) of the FD&C Act requires a manufacturer who intends to market a medical device to
`submit a premarket notification [510(k)] to the Agency at least 90 days before introducing the device
`onto the market. Premarket approval status is automatic for all devices found to be not substantially
`equivalent to preamendments devices. Based on the information provided in the notification, the
`Agency must determine whether the new device is substantially equivalent to a device already
`marketed or if it is not an equivalent device. A non equivalent device must have an approved
`premarket approval (PMA) application or be reclassified into Class I or Class II before being
`marketed. The final determination of whether a device is substantially equivalent or non equivalent
`resides with the FDA.
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`Premarket Notification [510(k)] - How to market a 510(k) Medical Device
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmis
`sions/PremarketNotification510k/default.htm)
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`Banned Devices
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`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm055910.htm
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`Section 516 of the FD&C Act authorizes the Agency to ban devices that present substantial
`deception or unreasonable and substantial risk of illness or injury. The procedures for banning a
`device are described below. If the Agency determines, on the basis of all available data and
`information and after consulting with the appropriate classification panel, that a device intended for
`human use presents such deception or risk of illness or injury, which cannot be corrected by a
`change in the labeling, then the Agency may publish a proposed regulation to ban the device in the
`Federal Register. If the deception or risk can be corrected by a change in the labeling, the Agency
`must notify the responsible person of the deception or risk, the change in labeling needed to correct
`it, and the time period within which the change should be made. If the labeling is not changed in the
`specified time and manner, then the Agency may publish the proposed regulation. After affording all
`interested persons an opportunity for an informal hearing on the proposal, the Agency will affirm,
`modify, or revoke the proposed regulation. If the proposal is affirmed or modified, the Agency will
`publish a final regulation banning the device. In this case, the device can no longer be legally
`marketed on and after the date of publication of the final regulation, except under an approved
`investigational device exemption
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDev
`iceExemptionIDE/default.htm). If the proposed regulation is revoked, the Agency will publish a
`notice to this effect in the Federal Register.
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`Notification and Other Remedies
`Section 518 of the Act deals with notification and other remedies for protecting the public from faulty
`or fraudulent devices.
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`Purpose Of Section 518
`The main purpose of Section 518 is protection of the public health. Section 518 offers FDA a way of
`assuring that hazardous products in the hands of consumers and other users are repaired,
`replaced, or refunded. In addition to the public health purpose of Section 518, this section also gives
`consumers a procedure for economic redress when they have been sold defective medical devices
`that present unreasonable risks.
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`Notification [518(a)]
`Under this Section of the FD&C Act, FDA may require manufacturers or other appropriate
`individuals to notify all health professionals who prescribe or use the device and any other person
`(including manufacturers, importers, distributors, retailers, and device users) of the health risks
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`resulting from the use of the violative device, so that these risks may be reduced or eliminated.
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`Threshold Requirements
`FDA can order notification if:
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`A device presents an unreasonable risk of substantial harm to public health;
`Notification is necessary to eliminate the risk; and
`No more practicable means are available under the FD&C Act to eliminate the risk.
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`Procedures
`The procedures for a notification order are simple. They involve only prior consultation with the
`persons who are to provide the notification.
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`Repair, Replacement, or Refund Provisions [518(b)]
`Section 518(b) authorizes the FDA, after offering an opportunity for an informal hearing, to order
`manufacturers, importers, or distributors to repair, replace, or refund the purchase price of devices
`that present unreasonable health risks.
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`Basic Criteria
`The FDA can order repair, replacement or refund (3-R) if, after opportunity for an informal hearing ,
`it determines that:
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`The device represents an unreasonable risk of substantial harm to the public health;
`The device was not designed and manufactured in accordance with the then prevailing state of
`the art;
`The risk is not due to negligent installation, maintenance, repair, or use of the device by persons
`other than a manufacturer, importer, distributor, or retailer; and
`Notification alone is insufficient, and repair, replacement, or refund is necessary.
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`Procedures
`The procedures for repair, replacement, or refund are complex and could result in multiple orders,
`regulatory hearings, and much delay if FDA and the manufacturer, or other responsible person, are
`unable to agree on a plan for addressing a risk. The Agency must consider available alternatives.
`Both notification orders and repair, replacement, or refund orders are discretionary. Before ordering
`notification, FDA must determine that no more practical means are available under the FD&C Act to
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`eliminate the risk. Although there is no requirement that such a determination be made before FDA
`orders repair, replacement, or refund, FDA must determine that notification alone is insufficient
`before ordering repair, replacement or refund.
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`FDA's alternatives to Section 518 are the following approaches:
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`Legal actions (seizures, injunctions, prosecutions);
`Regulations (e.g., banning or imposing restrictions on sale, distribution or use); and
`Recalls (under FDA's recall regulations).
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`Records and Reports On Devices
`Section 519 of the Act authorizes the FDA to promulgate regulations requiring manufacturers, importers,
`and distributors of devices to maintain records and reports to assure that devices are not adulterated or
`misbranded.
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`Records and reports regulations promulgated under Section 519:
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`May not impose requirements that are unduly burdensome to the manufacturer, importer, or
`distributor;
`Must state the reason and purpose for procedures requesting reports or information;
`Must state the reason and purpose for submission of reports or information;
`May not require that the identity of any patient be disclosed; and
`May not require a manufacturer, importer, or distributor to maintain or submit reports or
`information not in his/her possession.
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`Records and reports requirements do no apply to:
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`Practitioners who prescribe or administer devices solely in the course of their professional
`practice;
`Manufacturers or importers of devices used solely in research or teaching; and
`Other persons exempt by regulation.
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`Restricted Devices
`Under the provision of Section 520(e) of the Amendments, the FDA is authorized to restrict the sale,
`distribution, or use of a device if there cannot otherwise be reasonable assurance of its safety and
`effectiveness. A restricted device can only be sold on oral or written authorization by a licensed
`practitioner or under conditions specified by regulation. Devices such as cardiac pacemakers and
`heart valves, for example, require a practitioner's authorization. Hearing aids are restricted by a
`regulation which limits their sale to persons who have obtained a medical evaluation of their hearing
`loss by a physician within six months prior to the sale of the hearing aid. The labeling of hearing aids
`must provide information on their use and maintenance.
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`Quality System Regulation, Good Manufacturing Practices
`Section 520(f) of the Amendments authorizes the FDA to promulgate regulations requiring the
`methods used in, and the facilities and controls used for, the manufacturing, packing, storage, and
`installation of a device to conform to current good manufacturing practices (GMPs).
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`More in Regulatory Controls (Medical Devices)
`(/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm)
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`
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`General Controls for Medical Devices
`(/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm055910.htm)
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`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm055910.htm
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`Ex. 2028-0010