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Title 21-FOOD AND DRUGS is composed of nine volumes. The parts in these volumes are arranged in the following order: Parts 1–99, 100–169, 170-199, 200-299, 300-499, 500-599, 600-799, 800–1299 and 1300-end. The first eight volumes, containing parts 1–1299, comprise Chapter 1-Food and Drug Administration, Department of Health and Human Services. The ninth volume, containing part 1300 to end, includes Chapter II—Drug Enforcement Administration, Department of Justice, and Chapter III-Office of National Drug Control Policy. The contents of these volumes represent all current regulations codified under this title of the CFR as of April 1, 2006.

For this volume, Robert J. Sheehan was Chief Editor. The Code of Federal Regulations publication program is under the direction of Frances D. McDonald, assisted by Alomha S. Morris.

Title 21-Food and

Drugs

(This book contains Parts 800 to 1299)

Part

CHAPTER 1-Food and Drug Administration, Department of

Health and Human Services (Continued)

800

CHAPTER 1-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH

AND HUMAN SERVICES (CONTINUED)

EDITORIAL NOTES: 1. For nomenclature changes to chapter I see 59 FR 14366, Mar. 28, 1994. 2. For nomenclature changes to chapter I see 68 FR 24879, May 9, 2003. 3. For nomenclature changes to chapter I see 69 FR 13717, Mar. 24, 2004.

SUBCHAPTER H–MEDICAL DEVICES

Page

Part 800

801

803 806

807

...

808

809 810 812 813 814

820

General .........
Labeling ...
Medical device reporting .......
Medical devices; reports of corrections and remov-
als ..........

....
Establishment registration and device listing for

manufacturers and initial importers of devices
Exemptions from Federal preemption of State and

local medical device requirements .........
In vitro diagnostic products for human use ........
Medical device recall authority

.......
Investigational device exemptions ...........
[Reserved]
Premarket approval of medical devices
Quality system regulation ....
Medical device tracking requirements
Postmarket surveillance ........
Medical device classification procedures
Procedures for performance standards development
Clinical chemistry and clinical toxicology devices
Hematology and pathology devices .........
Immunology and microbiology devices ....
Anesthesiology devices .......
Cardiovascular devices .................
Dental devices .....
Ear, nose, and throat devices .............
Gastroenterology-urology devices .......
General and plastic surgery devices .....

116 138 151

821

822

157

860

861

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862 864 866 868 870 872 874

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876

352 365 383

878

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