Life Extending and Life Saving Device Act of 1997

[AI summary unavailable — showing source text] 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 condi…