Medical Device Amendments

(LATEST SUMMARY)

Medical Device Amendments - =Title I: Preliminary Classification of Medical Devices= - Provides that the Secretary of Health, Education, and Welfaare shall appoint and organize separate classification panels of experts, qualified by scientific training and experience, to review and classify devices intended for human use into appropriate categories based on the safety and effectiveness of such devices. Requires each panel to reveiw all devices intended for human use within its respective scientific field for purposes of appropriate classification and to submit within one year of its appointment a report of its findings and conclusions to the Secretary. Requires that to the maximum extent practical the panel or panels shall provide an opportunity for any interested person to submit data and views on the classification of a device (or type or class of device).

States the criteria to be used by the panels in determining their recommendations for the classification of devices.

=Title II: Authority to establish Performance Standards= - Provides that whenever in the judgment of the Secretary such action is appropriate to assure effectiveness or to reduce or eliminate unreasonable risk of illness or injury associated with exposure to or use of a device (including the need for uniformity and compatibility with systems or environments in which it is intended to be used) and for which other means may not be appropriate to reduce or eliminate such risk of illness or injury he shall promulgate for any device, or type or class of device, for which a performance standard has been determined to be appropriate, a performance standard relating to safety and effectiveness.

Provides for periodic evaluation of the adequacy of standards. Directs the Secretary to consult with other Federal agencies and organizations.

Requires the Secretary to publish in the Federal Register a notice that proceedings have been initiated to promulgate a device standard. Specifies the content of such notification.

Directs the Secretary to accept one or more offers to develop a proposed standard sand to publish in the Federal Register names and addresses of persons whose offers are accepted and the terms of such offers.

Directs the Secretary to prescribe regulations governing development of proposed standards. Sets forth alternatives to the development of standards, including: (1) the use of existing standards; and (2) the development of standards by the Secretary.

Provides procedures for the promulgation, amendment, or revocation of performance standards.

Authorizes the Secretary to appoint independent advisory committees, to which could be referred any matters involving a proposed device standard, prior to or after its publication in the Federal Register. Prescribes the composition of such committees.

Requires that every manufacturer of a device shall assure the Secretary, at such times and in such manner and form as the Secretary shall by regulation prescribe, that testing methods prescribed by the performance standards show the device to comply therewith, or that the device was manufactured under a program of guality control which is in accord with current good manufacturing practice designed to assure such compliance.

=Title III: Scientific Review of Certain Medical Devices= - States that the Secretary may declare that a device (or type or class of device) for which scientific review has been determined to be appropriate shall be subject to scientific review with respect to any particular use of intended use thereof if, after consulatation with the appropriate panel or panels, he finds that: (1) such review is appropriate to assure effectiveness or is appropriate to reduce or eliminate unreasonable risk of illness or injury associated with exposure to or use of a device and (2) other means available to the Secretary may not be appropriate to reduce or eliminate such risk of illness or injury. Provides that the Secretary may declare that a device (or type or class of device shall be subject to scientific review under this section with respect to any particular use of intended use thereof if he: determines that scientific reveiw for any device is appropriate to protect the public health and safety and (2) finds that other means available to the Secretary may not be appropriate to reduce or iliminate such risk of illness or injury.

Requires the declaration to be by regulation. Permits the promulgation of such regulation to be appealed to the courts within thirty days after publication in the Federal Register.

Provides that for the purpose of reviewing plans and product development the Secretary shall utilize the standing advisory panels.

Provides for the Scientific reveiw of a device which has been declared subject to such reveiw.

Sets forth the necessary contents of an application for scientific review.

Permits the applicant to obtain judicial review of a final order of the Secretary denying or withdrawing approval of an application or revoking an exemption.

Provides for exemptions from the requirement of approval of an application in specified circumstances.

=Title IV: Notification of Defective Devices; Repair or Replacement= - Requires every person who acquires information which reasonably supports the conclusion that a device intended for human use which has been produced, assembled, distributed, or imported by him (1) contains a defect which could create a substantial risk to the public health or safety, or (2) on or after the effective date of an applicable performance standard fails to comply with such standard, to immediately notify the Secretary of such defect or failure to comply if such device has left the control of the manufacturer.

=Title V: Requirement of Good Manufacturing Practice= - Requires that a device, and the methods used in its manufacture, must conform to good manufacturing practice.

=Title VI: Records and Reports; Inspection and Registration of Establishments; Official Names= - Requires persons manufacturing, processing, repacking, labeling, or distributing a device subject to a standard which is in effect, or with respect to which there is in effect an approval of an application for scientific review, to maintain records and to make reports to the Secretary on clinical experience and other data relating to safety or effectiveness of such device, or possibility of adulteration or misbranding.

=Title VII: General Provisions= - Establishes an Advisory Council on Devices to advise the Secretary on policy matters relating to carrying out provisions of the Act.

Authorizes the Secretary to plan, conduct, coordinate, and support research and education dealing with the safety and effectiveness of medical devices and into the causes and prevention of injuries or other health impairments associated with exposure to or use of such devices.

Provides that nothing in this Act shall be construed as preventing the Federal Government or the government of any State or political subdivision thereof from establishhing stricter safety requirements than the otherwise applicable Federal requirements.

Permits the Secretary to disclose information relating to trade secrets to a contractor in furtherance of provisions of the Act, subject to the contractor's observance of such security precautions as are prescribed in regulations.

Defines the term "device" to mean instruments, apparatus, implements, machines, contrivances, implants, in vitro reagents, or similar articles, including their components, parts and accessories which are: (1) recognized in the official U.S. Pharmacopeia or National Formulary, or any supplement to them, or (2) intended for use in diagnosis, treatment, or prevention of disease in man or other animals, or (3) intended to affect any structure or any function of the body of man or other animals, and (4) not achieving any of their principal purposes through chemical action within or on the body of man or other animals and which are not dependent upon being metabolized for achievement of their principal purposes. Defines the term "prescription device".

Makes various technical amendments to the Federal Food, Drug, and Cosmetic Act to make existing law applicable to devices.