Life Extending and Life Saving Device Act of 1997

Life Extending and Life Saving Device Act of 1997 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to declare that the mission of the Food and Drug Administration (FDA), with regard to drugs, biological products, and devices, is to promote and protect the health of the American people.

(Sec. 4) Requires harmonization of FDCA requirements with similar foreign laws through the International Conference on Harmonization.

(Sec. 5) Modifies provisions relating to reporting before introducing a device into interstate commerce.

(Sec. 6) Requires, for specified provisions, that the safety and effectiveness of a device be determined (among other factors) with respect to the persons for whose use the device is represented or intended by the person legally responsible for labeling the device.

(Sec. 7) Regulates the circumstances in which well-controlled clinical investigations of device effectiveness are required. Excludes certain measures from the determination of effectiveness.

(Sec. 8) Revises premarket approval application requirements and procedures.

(Sec. 9) Amends provisions relating to investigational use to mandate updating of the regulations regarding the procedures and conditions under which devices intended for human use may be granted exemptions from FDCA requirements.

(Sec. 10) Regulates the classification of in vitro diagnostic test systems and special purpose reagents.

(Sec. 12) Allows accredited organizations and individuals to conduct good manufacturing practice inspections. Modifies other inspection-related requirements and procedures. Provides for accreditation.

(Sec. 14) Requires that FDA research activities relating to drugs, devices, and biological products and authorized under specified Public Health Service Act provisions relate to the review and approval of drugs, devices, and biological products. Allows FDA collaboration in such activities with various entities, including the drug and device industry. Amends the FDA mission statement to require that research conducted by or for the FDA be: (1) solely related directly to the regulatory mission or professional staff development related to that mission; and (2) limited to the minimum necessary.

(Sec. 15) Mandates recognition of nationally or internationally recognized consensus standards in determining safety or effectiveness or compliance with FDCA requirements. Revises other performance and compliance requirements.

(Sec. 16) Revises requirements regarding a food, drug, device, or cosmetic intended for export, including regarding new drugs and biological products. Repeals provisions relating to exports of certain unapproved products.

(Sec. 17) Mandates publication of a proposed regulation reclassifying certain class III devices as class II.

(Sec. 18) Modifies device tracking and postmarket surveillance requirements.

(Sec. 20) Allows, notwithstanding specified provisions of the Public Health Service Act (PHSA), dissemination to individuals and entities involved in health care (including practitioners, managed care organizations, insurers, and governmental agencies) written information (or an oral or written summary thereof) concerning: (1) a treatment use for an investigational new drug or an investigational biological product approved for that use; or (2) a use (whether or not the use is contained in the official labeling) of a new drug or a biological product for which a new drug application, an abbreviated new drug application, a certification of an antibiotic drug, or a product license issued under the PHSA has been approved. Sets forth restrictions and requirements.

Allows, notwithstanding any other provision of law, dissemination to individuals and entities involved in health care (including practitioners, managed care organizations, insurers, and governmental agencies) written or oral information relating to a use (whether or not described in the official labeling) of a device registered under specified FDCA provisions. Sets forth restrictions and requirements. Declares that, notwithstanding any other provision of law, the dissemination shall not be construed as evidence of a new intended use or considered as labeling, adulteration, or misbranding of the device.

Sets forth recordkeeping, reporting, and device tracking requirements. Mandates deletion of all regulations in a specified part requiring distributors, other than importers, to report deaths, serious injuries or illnesses, and malfunctions related to devices.

Exempts a person from penalties for violation of specified FDCA provisions if the person acted in good faith, had no reason to believe that the person's acts violated the law, and had no prior notice that the acts constituted FDCA violations.

Mandates deletion of all regulations in a specified part of the Code of Federal Regulations requiring reporting of device malfunctions.