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Device Advice All CDRH

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• 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.

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

Unless otherwise exempted, the General Controls provisions of the Amendments are applicable to all devices regardless of their classification status.

KEY POINTS

• 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:
  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:
  1. Adulteration;
  2. Misbranding;
  3. Device registration and listing;
  4. Premarket notification;
  5. Banned devices;
  6. Notification and repair, replacement, and refund;
  7. Records and reports;
  8. Restricted devices; and
  9. Good Manufacturing Practices.

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:

• 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.

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:

• 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).

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:

Drugs and Device Misbranding Provisions

A drug or device is deemed to be misbranded if:

• Its labeling is false and misleading.
• Its packaging does not bear a label containing:
  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.

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:

• 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:
  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).

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

Medical Device Labeling Information

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.

Information on FDA requirements for establishment registration (FDA Form 2891)

Device Listing Requirements

FDA requirements for medical device listing (FDA Form 2892)

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.

Premarket Notification [510(k)] - How to market a 510(k) Medical Device

Banned Devices

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. If the proposed regulation is revoked, the Agency will publish a notice to this effect in the Federal Register.

Notification and Other Remedies

Section 518 of the Act deals with notification and other remedies for protecting the public from faulty or fraudulent devices.

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.

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 resulting from the use of the violative device, so that these risks may be reduced or eliminated.

Threshold Requirements

FDA can order notification if:

• 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.

Procedures

The procedures for a notification order are simple. They involve only prior consultation with the persons who are to provide the notification.

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.

Basic Criteria

The FDA can order repair, replacement or refund (3-R) if, after opportunity for an informal hearing , it determines that:

• 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.

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 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.

FDA's alternatives to Section 518 are the following approaches:

• Legal actions (seizures, injunctions, prosecutions);
• Regulations (e.g., banning or imposing restrictions on sale, distribution or use); and
• Recalls (under FDA's recall regulations).

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.

Records and reports regulations promulgated under Section 519:

• 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.

Records and reports requirements do no apply to:

• 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.

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.

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).

Updated 4/16/1998

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