Reseña del libro "Code of Federal Regulations Title 21, Volume 8, April 1, 2015 (en Inglés)"
21 CFR Parts 800 to 1299 covers the U. S. Food and Drug Administration within the U.S. Department of Health and Human Services. Within this volume, you will find rules, procedures, and regulations pertaining to medical devices, such as cardiovascular devices, dentistry devices, orthopedic, gastroenterology-urology, in vitro, anesthesiology, and more. Plus, you will find rules, procedures, and regulations relating to mammography quality standards, radiological health, tobacco products, human tissue intended for transplantation, and more.Health care device manufacturers, hospital radiological and other medical technicians and departments, physicians, nurses, out-patient clinics' personnel, and health care policy advocates may be interested in this volume.Code of Federal Regulations Title 21, Volume 8, April 1, 2015Containing parts Parts 800 to 1299Part 800; GENERALPart 801; LABELINGPart 803; MEDICAL DEVICE REPORTING; (Eff. Until 8-14-15)Part 806; MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALSPart 807; ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICESPart 808; EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTSPart 809; IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USEPart 810; MEDICAL DEVICE RECALL AUTHORITYPart 812; INVESTIGATIONAL DEVICE EXEMPTIONSPart 813; ReservedPart 814; PREMARKET APPROVAL OF MEDICAL DEVICESPart 820; QUALITY SYSTEM REGULATIONPart 821; MEDICAL DEVICE TRACKING REQUIREMENTSPart 822; POSTMARKET SURVEILLANCEPart 830; UNIQUE DEVICE IDENTIFICATIONPart 860; MEDICAL DEVICE CLASSIFICATION PROCEDURESPart 861; PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENTPart 862; CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICESPart 864; HEMATOLOGY AND PATHOLOGY DEVICESPart 866; IMMUNOLOGY AND MICROBIOLOGY DEVICESPart 868; ANESTHESIOLOGY DEVICESPart 870; CARDIOVASCULAR DEVICESPart 872; DENTAL DEVICESPart 874; EAR, NOSE, AND THROAT DEVICESPart 876; GASTROENTEROLOGY-UROLOGY DEVICESPart 878; GENERAL AND PLASTIC SURGERY DEVICESPart 880; GENERAL HOSPITAL AND PERSONAL USE DEVICESPart 882; NEUROLOGICAL DEVICESPart 884; OBSTETRICAL AND GYNECOLOGICAL DEVICESPart 886; OPHTHALMIC DEVICESPart 888; ORTHOPEDIC DEVICESPart 890; PHYSICAL MEDICINE DEVICESPart 892; RADIOLOGY DEVICESPart 895; BANNED DEVICESPart 898; PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLESPart 900; MAMMOGRAPHYPart 1000; GENERALPart 1002; RECORDS AND REPORTSPart 1003; NOTIFICATION OF DEFECTS OR FAILURE TO COMPLYPart 1004; REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTSPart 1005; IMPORTATION OF ELECTRONIC PRODUCTSPart 1010; PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERALPart 1020; PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTSPart 1030; PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTSPart 1040; PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTSPart 1050; PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTSPart 1107; ESTABLISHMENT REGISTRATION, PRODUCT LISTING, AND SUBSTANTIAL EQUIVALENCE REPORTSPart 1140; CIGARETTES AND SMOKELESS TOBACCOPart 1141; CIGARETTE PACKAGE AND ADVERTISING WARNINGSPart 1150; USER FEESPart 1210; REGULATIONS UNDER THE FEDERAL IMPORT MILK ACTPart 1230; REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACTPart 1240; CONTROL OF COMMUNICABLE DISEASESPart 1250; INTERSTATE CONVEYANCE SANITATIONParts 1251-1269; ReservedPart 1270; HUMAN TISSUE INTENDED FOR TRANSPLANTATIONPart 1271; HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTSParts 1272-1299; Reserved