Food and Drugs: Parts 800 to 1299; Revised as of April 1, 2009

Front Cover
Government Printing Office, 2009 - Law - 785 pages
The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the United States Federal Government.
 

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Contents

1 Nomenclature changes to chapter I appear at 59 FR 14366 Mar 28 1994
5
Labeling
15
Medical device reporting
41
Medical devices reports of corrections and remov als
60
Establishment registration and device listing for manufacturers and initial importers of devices
69
Exemptions from Federal preemption of State and local medical device requirements
77
Title
80
In vitro diagnostic products for human use
86
Obstetrical and gynecological devices
443
Ophthalmic devices
466
Orthopedic devices
489
Physical medicine devices
515
Radiology devices
532
Banned devices
546
Performance standard for electrode lead wires and patient cables
551
SUBCHAPTER IMAMMOGRAPHY QUALITY STANDARDS ACT 900 Mammography
553

Medical device recall authority
94
Investigational device exemptions
101
Premarket approval of medical devices
119
Quality system regulation
142
Medical device tracking requirements
156
Postmarket surveillance
161
Medical device classification procedures
170
Procedures for performance standards development
182
Clinical chemistry and clinical toxicology devices
186
Hematology and pathology devices
225
Immunology and microbiology devices
247
Anesthesiology devices
289
Cardiovascular devices
311
Dental devices
332
Ear nose and throat devices
359
Gastroenterologyurology devices
372
General and plastic surgery devices
390
General hospital and personal use devices
405
Part Page 882 Neurological devices
427
SUBCHAPTER JRADIOLOGICAL HEALTH 1000 General
588
Records and reports
597
Notification of defects or failure to comply
605
Repurchase repairs or replacement of electronic products
609
Importation of electronic products
611
General
614
Performance standards for ionizing radiation emit ting products
620
Performance standards for microwave and radio
653
frequency emitting products
656
Performance standards for sonic infrasonic and ultrasonic radiationemitting products
679
SUBCHAPTER K RESERVED
682
SUBCHAPTER LREGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION 1210 Re...
683
Regulations under the Federal Caustic Poison Act
686
Control of communicable diseases
693
Interstate conveyance sanitation
699
12511269 Reserved 1270 Human tissue intended for transplantation
710
Human cells tissues and cellular and tissuebased products
715
12721299 Reserved
741
Copyright

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Published by the Office of the Federal Register, National Archives and Records Administration. Official U.S. Government Edition.

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