Page:United States Statutes at Large Volume 90 Part 1.djvu/589

 PUBLIC LAW 94-295—MAY 28, 1976

90 STAT. 539

Public Law 94-295 94th Congress An Act To amend the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and for other purposes.

May 28. 1976 [S. 510]

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, Medical Device SHORT TITLE AND TABLE OF CONTENTS

Amendments of 1976. 21 USC 301 note.

1. (a) This Act may be cited as the "Medical Device Amendments of 1976". (b) Whenever in this Act (other than in section 3(a)(1)(B)) an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act. 21 USC 301. SECTION

TABLE OF CONTENTS Sec. 1. Short title and table of contents. Sec. 2. Regulation of medical devices. "Sec. 513. C'assitlcation of devices intended for human use. " (a) Device classes. "(b) Classification; classification panels. "(c) Classification panel organization and operation. " (d) Classification. " (e) Classification changes. "(f) Initial classification of certain devices. "(g) Information. " (h) Definitions. "Sec. 514. Performance standards. " (a) Provisions of standards. "(b) Initiation of a proceeding for a performance standard. "(c) Invitation for standards. " (d) Acceptance of certain existing standards. " (e) Acceptance of offer to develop standard. "(f) Development of standard by Secretary after publication . of subsection (c) notice. "(g) Establishment of a standard. "Sec. 515. Premarket approval. " (a) General requirement. "(b) Regulation to require premarket approval. "(c) Application for premarket approval. " (d) Action on an application for premarket approval. " (e) Withdrawal of approval of application. "(f) Product development protocol. "(g) Revievp. " (h) Service of orders. "Sec. 516. Banned devices. " (a) General rule. " (b) Special effective date. "Sec. 517. Judicial review. " (a) Application of section. "(b) Additional data, views, and arguments. "(c) Standard for review. " (d) Finality of judgments. " (e) Other remedies. "(f) Statement of reasons.

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