Medical Device Safety Act

Medical Device Safety Act - Title I: Authority to Establish Standards - Authorizes the Secretary of Health, Education, and Welfare to establish standards, under the Federal Food, Drug, and Cosmetic Act, for medical devices when such action will protect public health and safety.

Authorizes the Secretary to establish mandatory standards relating to the composition, properties, or performance of a medical device or class of medical devices. Provides that the Secretary may utilize conferences, workshops, and other means by which nongovernmental experts could participate in the development of standards.

Allows any person adversely affected by such standards to refer the matter to an independent advisory committee for its recommendations.

Title II: Premarket Clearance of Certain Medical Devices - Sets forth conditions for when a premarketing clearance is required. States that a device is to be deemed unsafe, unreliable, or ineffective when: (1) the device is not generally recognized by experts, qualified by scientific training or experience, to be safe, reliable, or effective for use under the conditions prescribed, suggested or recommended; and (2) the device is intended for or is used within the human body, intended to be used for subjecting the human body to some process, or after investigation is found to be ineffective, unsafe, or unreliable.

Exempts those devices: (a) for which a new-device application has been filed, or (b) which are for use only in animals other than man, or (c) which are otherwise exempted by the terms of this Act.

Prescribes the contents and procedures for new device applications to comply with the clearance procedure. Provides that these applications must contain: (1) information and data to show the safety, reliability, and effectiveness of the device; (2) composition, properties, and principles of operation; (3) methods and controls used in manufacture; (4) identification of the applicable standard and information to show that the device meets the standard; (5) samples of the device; (6) specimens of labeling; and (7) other requirements the Secretary may require.

Requires the Secretary to act on an application within 180 days after filing by approving, denying and affording an opportunity for hearing, or suspending the time limit pending the report of an advisory committee. Provides that an application shall be disapproved when: (1) the device is not safe or reliable under conditions prescribed; (2) manufacturing or processing controls do not meet good manufacturing practices; (3) lack of substantial evidence that the device has the effect it purports; and (4) has false or misleading labeling. Authorizes the Secretary to withdraw approval of an application where: (1) other data, or later evidence, indicates that the device is unsafe or unreliable; (2) new information shows the device to be ineffective; (3) the application contains untrue statements of material fact; (4) there is a failure to maintain records as required elsewhere in this Act; (5) good manufacturing practices are not employed as required elsewhere in this Act; or (6) on the basis of new information, the labeling is false or misleading. Authorizes the Secretary, where an imminent health or safety hazard is involved, to suspend approval immediately and to provide for an expedited hearing into the matter.

Authorizes the use of a referral committee for an opportunity for a hearing on an application or on the Secretary's action to obtain the committee's report and recommendations. Provides applicants with the right of appeal and to obtain judicial review. Establishes an exemption for devices used solely for investigational purposes by persons qualified to conduct such investigation, conditioned upon: (1) the existence of an adequate plan of investigation; (2) a written agreement that the use of the device will be under the supervision of the investigator in cases where the device is for human use; (3) that records and data obtained from the investigation are kept and available; and (4) other conditions determined by the Secretary to assure public health and safety.

Exempts from the application procedure any device which fully conforms to an applicable standard established under the Public Health Service Act, or meets standards about to be announced or implemented, devices made upon order by a practitioner, where such a device is not generally available in finished form or in existing commercial channels, or where the device is for the use of a named patient, or for the sole use of a practitioner in the course of his professional practice. Provides exemptions for devices for which requirements are found not to be necessary for the protection of the public health and safety, with the unanimous consent of the Advisory Council on Medical Devices; and for devices licensed by the Atomic Energy Commission, where the Secretary finds regulation duplicative.

Title III: Requirement of Good Manufacturing Practice - Provides that a device is "adulterated" if the method and controls used to manufacture the device do not conform with good manufacturing practice to assure that such a device is safe and reliable and that it has the characteristics it purports to have.

Title IV : Records and Reports; Registration of Establishments - Requires that manufacturers, processors, and distributors of devices subject to standards keep records and make reports to the Secretary relating clinical experience and other data which bears on the safety, reliability, and effectiveness of such devices. Exempts from these requirements the following: (1) pharmacies operating in conformance with applicable local laws; (2) practitioners, licensed by law, who manufacture devices solely for use in the course of their professional practice; (3) persons who manufacture devices solely for use in research or teaching, and not for sale; (4) devices, no part of which has been in interstate commerce and which is not intended for interstate commerce; and (5) other classes, as determined by the Secretary.

Title V: Advisory Council on Devices, Etc. - Provides for the creation of an Advisory Council on Devices within the Department of Health, Education, and Welfare to advise the Secretary on policy matters in carrying out the provisions of this bill. Requires that members be selected with a view toward their special knowledge of the problems involved in regulating various kinds of devices.

Title VI: Effective Dates and Transitional Provisions - Makes the provisions of this Act effective on the date of enactment with various exceptions.