Page:United States Statutes at Large Volume 90 Part 1.djvu/590

 90 STAT. 540

PUBLIC LAW 94-295—MAY 28, 1976 TABLE OF CONTENTS—Continued

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Sec. 2. Regulation of medical devices.—Continued "Sec. 518. Notification and other remedies., " (a) Notification. •"(b) Repair, replacement, or refund. " (c) Reimbursement. " (d) Effect on other liability. -r ! "Sec. 519. Records and reports on devices. ? " (a) General rule. " (b) Persons exempt. "Sec. 520. General provisions respecting control of devices Intended for human use. " (a) General rule. ' ^' > " (b) Custom devices. "(c) Trade secrets. . . " (d) Notices and findings. " (e) Restricted devices. "(f) Good manufacturing practice requirements. " (g) Exemption for devices for investigational use. " (h) Release of safety and effectiveness information, " (i) Proceedings of advisory panels and committees. " (j) Traceability requirements. " (k) Research and development. "(1) Transitional provisions for devices considered as new drugs or antibiotic drugs. "Sec. 521. State and local requirements respecting devices. " (a) General rule. "(b) Exempt requirements.". Sec. 3. Conforming amendments. (a) Amendments to section 201. (b) Amendments to section 301. (c) Amendments to section 304. (d) Amendments to section 501. (e) Amendments to section 502. (f) Amendments to section 801. Sec. 4. Registration of device manufacturers. Sec. 5. Device established and oflScial names. Sec. 6. Inspections relating to devices. Sec. 7. Administrative restraint. . i | N. ' Sec. 8. Confidential information; presumption. Sec. 9. Color additives. Sec. 10. Assistance for small manufacturers of devices. REGULATION OT MEDICAL DEVICES

SEC. 2. Chapter V is amended by adding after section 512 the following new sections: "CLASSIFICATION' or DEVICES INTENDED FOR HUMAN USE

"Device Classes 21 USC 360c.

«SEC. 513. (a)(1) There are established the following classes of devices intended for human use: " (A) CLASS I, GENERAL CONTROLS.—

21 USC 351,352, 360. w *?L.^qfik 562, 564, 565., ^

" (i) A device for which the controls authorized by or under section 501, 502, 510, 516, 518, 519, or 520 or any combination of such sections are sufficient to provide reasonable assurance ®^ safety and effectiveness of the device. «^jj^ ^ device for which insufficient information exists to determine that the controls referred to in clause (i) are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish a performance standard to provide such assurance, but because it— " (I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is

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