The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1991 The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. |
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1.–5. rezultāts no 67.
78. lappuse
... Monitor , ” when used as a noun , means an individual designated by a sponsor or contract research organiza- tion to oversee the progress of an in- vestigation . The monitor may be an employee of a sponsor or a consultant to the sponsor ...
... Monitor , ” when used as a noun , means an individual designated by a sponsor or contract research organiza- tion to oversee the progress of an in- vestigation . The monitor may be an employee of a sponsor or a consultant to the sponsor ...
81. lappuse
... monitor . ( f ) Labeling . Copies of all labeling for the device . ( g ) Consent materials . Copies of all forms and informational materials to be provided to subjects to obtain in- formed consent . ( h ) IRB information . A list of the ...
... monitor . ( f ) Labeling . Copies of all labeling for the device . ( g ) Consent materials . Copies of all forms and informational materials to be provided to subjects to obtain in- formed consent . ( h ) IRB information . A list of the ...
84. lappuse
... monitors . A sponsor shall select monitors qualified by training and experience to monitor the investigational study in accord- ance with this part and other applica- ble FDA regulations . § 812.45 Informing investigators . A sponsor ...
... monitors . A sponsor shall select monitors qualified by training and experience to monitor the investigational study in accord- ance with this part and other applica- ble FDA regulations . § 812.45 Informing investigators . A sponsor ...
86. lappuse
... monitor , or FDA , including required reports . ( 2 ) Records of receipt , use or disposi- tion of a device that relate to : ( i ) The type and quantity of the device , the dates of its receipt , and the batch number or code mark . ( ii ) ...
... monitor , or FDA , including required reports . ( 2 ) Records of receipt , use or disposi- tion of a device that relate to : ( i ) The type and quantity of the device , the dates of its receipt , and the batch number or code mark . ( ii ) ...
87. lappuse
... monitor , and the reviewing IRB at regular in- tervals , but in no event less often than yearly . ( 4 ) Deviations from the investiga- tional plan . An investigator shall notify the sponsor and the reviewing IRB ( see § 56.108 ( a ) ( 3 ) ...
... monitor , and the reviewing IRB at regular in- tervals , but in no event less often than yearly . ( 4 ) Deviations from the investiga- tional plan . An investigator shall notify the sponsor and the reviewing IRB ( see § 56.108 ( a ) ( 3 ) ...
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AC-powered accessories amended at 54 ance standards application ation blood bone cement Cardiopulmonary bypass catheter chapter Class II perform Class III premar Classification clinical clude commercially distributed Commissioner complaint files component controls current good manufacturing Date PMA denture device includes device intended device is exempt device that consists diagnosis and treatment disease Drug Administration Effective date added equipment Federal Food Food and Drug hearing aid Identification immunological test system implanted intended for medical intended to measure intraocular lens June 12 ket approval labeling laser laser product lens manufacturing practice medical purposes ment for premarket monitor notice of completion operation paragraph patient PDP is required plasma PMA or notice premarket approval premarket notification procedures procedures in Subpart prosthesis radiation reagents respect to complaint revised section 515 Sept serological serum specific sponsor submitted surgical test system tion tissue tube type of device x-ray system
Populāri fragmenti
546. lappuse - Milk is the fresh, clean, lacteal secretion obtained by the complete milking of one or more healthy cows, properly fed and kept, excluding that obtained within fifteen days before and...
547. lappuse - Cream is that portion of milk, rich in milk fat, which rises to the surface of milk on standing, or is separated from it by centrifugal force, is fresh and clean and contains not less than eighteen (18) per cent of milk fat.
557. lappuse - ... for its release and delivery to the importer; but if upon such final reexamination by such board the tea shall be found to be inferior in purity, quality, and fitness for consumption...
71. lappuse - label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. (1) The...
22. lappuse - Act (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling, or repacking establishment.
182. lappuse - ... (the ratio of the velocity of light in a vacuum to the velocity of light in the solution).
71. lappuse - label" means a display of written, printed, or graphic matter upon the immediate container of any substance; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears...
20. lappuse - ... because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug...
546. lappuse - To regulate the importation of milk and cream into the United States for the purpose of promoting the dairy industry of the United States and protecting the public health" shall be known and referred to as "the Federal Import Milk Act.
572. lappuse - The Surgeon General, with the approval of the Secretary is authorized to make and enforce such regulations as in his judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.