Medical Device Amendments of 1976

(Conference report filed in House, H. Rept. 94-1090)

Medical Device Amendments - Provides for the classification of medical devices intended for human use based upon their safety and effectiveness. Describes such classification as follows: (1) Class I includes devices not purported to be for a use which is of substantial importance in supporting, sustaining, or preventing impairment of human life or health and do not present a potential unreasonable risk of illness or injury, and for which general controls, as defined are sufficient; (2) Class II includes devices for which it is necessary to establish a performance standard to provide reasonable assurance of their safety and effectiveness; and (3) Class III includes devices for which there is insufficient information for the establishment of a performance standard to provide reasonable assurance of their safety and effectiveness, are purported to be for a use which is of substantial importance in supporting, sustaining, or preventing impairment of human life or health, or present a potential unreasonable risk of illness or injury.

Gives the Secretary of Health, Education, and Welfare responsibility for classifying all such devices. Authorizes the Secretary to establish panels of experts for the purpose of securing recommendations with respect to such classifications. Provides that any such recommendation shall contain a summary of the data upon which the recommendation is based, and an identification of the risks to health presented by the device.

Provides that, based on new information respecting a device, the Secretary may, upon his own initiative or upon petition of any interested person, by regulation: (1) change the classification of such device; and (2) revoke, because of the change, any regulation in effect with respect to such device.

Places devices intended for human use which were not placed in interstate commerce before enactment of this Act in Class III. Sets forth procedures by which a manufacturer or importer may petition for such a device to be placed in Class I or II.

Authorizes the Secretary, by regulation, to establish a performance standard for a Class II device.

Sets forth criteria to be followed in such standard which will assure that the device is safe and effective. Directs the Secretary to provide for periodic evaluation of performance standards established under this Act. Establishes procedures to be followed by the Secretary in developing and changing such standards.

Provides that the Secretary shall publish in the Federal Register a notice inviting any person, including any Federal agency, to submit an existing standard or an offer to develop such a standard. Requires the Secretary to obtain from the offeror such information concerning the offeror as the Secretary determines is necessary to disclose potential conflicts of interests and the reliability of the offeror.

States that if a standard or offer to create a standard is submitted to the Secretary which he does not accept, he shall publish in the Federal Register notice of that fact together with the reasons therefor.

Authorizes the Secretary to accept offers to develop a proposed standard for a device. Allows the Secretary to contribute to the offeror's costs in developing a proposed standard. Provides for the development of performance standards by the Secretary when no other means are available.

Requires premarket approval for Class III devices. Establishes procedures for such approval. Sets forth criteria upon which the approval or disapproval of such devices shall be based, including a lack of reasonable assurances by the applicant that such device is safe for use under the conditions prescribed in the proposed labeling.

Allows the Secretary to withdraw his premarket approval of a device in specified circumstances. Sets forth procedures to be followed for the withdrawal of such approval.

States that in the case of a Class III device which is required to have an approval of an application submitted, such device shall be considered as having such an approval if a notice of completion of testing conducted in accordance with a product development protocol has been completed as required in the Act.

Authorizes the Secretary to ban devices intended for human use if he finds that: (1) they present a substantial deception or a substantial risk of illness or human injury; and (2) such deception or risk could be eliminated by corrective labeling but the manufacturer does not do so. Sets forth procedures governing the banning of such devices.

Provides that the United States Court of Appeals for the District of Columbia shall hear appeals by any person adversely affected by a decision, rule, or order of the Secretary under this Act.

Provides that if the Secretary determines that a device intended for human use presents an unreasonable risk of substantial harm to the public health, and that notification of such risk is necessary, he may issue such order as may be necessary to assure that adequate notification is provided by the persons and means best suited under the circumstances, to all persons who should receive such notification in order to eliminate such risk.

Authorizes the Secretary to require a manufacturer of a medical device intended for human use which: (1) presents a substantial risk of harm to the public health; and (2) was not properly designed or manufactured, to repair, replace, or refund the purchase price of such device at no cost to the person using it.

Requires every person who is a manufacturer, importer, or distributor of a medical device intended for human use to establish and maintain such records as the Secretary may by regulation direct.

Authorizes the Secretary to require that a device be limited to sale or distribution by prescription of a licensed medical practitioner. Authorizes the Secretary to establish mandatory manufacturing methods for medical devices.

Directs the Secretary to prescribe procedures under which devices intended for human use may be granted an exemption from the requirements of this Act to permit the investigational use of such devices by experts qualified by scientific training and experience to investigate the safety and effectiveness of such devices.

Requires the Secretary to promulgate regulations under which a detailed summary of information respecting the safety and effectiveness of a device shall be made available to the public. States that such summaries shall include information respecting adverse effects of the device on health.

Makes conforming amendments to the Federal Food, Drug, and Cosmetic Act. Extends specified sections of such Act relating to labeling, inspection, and seizures to medical devices.

Authorizes the Secretary to prohibit the introduction into interstate commerce for export of specified devices, drugs, and new animal drugs or animal feed bearing new animal drugs.

Requires manufacturers of medical devices intended for human use to register with the Secretary of Health, Education, and Welfare and to provide specified information concerning such devices.

Directs the Secretary to establish within the Department of Health, Education, and Welfare an identifiable office to provide technical and other nonfinancial assistance to small manufacturers of medical devices to assist them in complying with the requirements of the Food, Drug, and Cosmetic Act.