Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexU.S. General Services Administration, National Archives and Records Service, Office of the Federal Register, 1990 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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1.5. rezultāts no 64.
76. lappuse
... Monitor , " when used as a noun , means an individual designated by a 21 CFR Ch . I ( 4-1-90 Edition ) sponsor or contract research organiza- tion to oversee the progress of an in- vestigation . The monitor may be an employee of a ...
... Monitor , " when used as a noun , means an individual designated by a 21 CFR Ch . I ( 4-1-90 Edition ) sponsor or contract research organiza- tion to oversee the progress of an in- vestigation . The monitor may be an employee of a ...
79. 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 ...
82. 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 ...
84. 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 ) ...
85. 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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accessories amended at 53 ance standards application blood bone cement Cardiopulmonary bypass catheter cation chapter Class II perform Class III premar Classification clinical clude commercially distributed Commissioner complaint files component contact lens controls Date PMA denture device includes device intended device is exempt device that consists disease Drug Administration effective date emission equipment Federal Food fluid Food and Drug Health hearing aid Identification immunological test system implanted intended for medical intended to measure intraocular lens investigational study June 12 ket approval labeling laser laser product lens manufacturing practice means medical device medical purposes ment for premarket monitor notice of completion package paragraph patient PDP is required plasma PMA or notice premarket approval premarket notification procedures procedures in Subpart prosthesis radiation respect to complaint section 515 Sept serological serum sponsor statement submit surgical tion tissue tube type of device x-ray system
Populāri fragmenti
518. lappuse - Milk is the whole, fresh, clean, lacteal secretion obtained by the complete milking of one or more healthy cows, properly fed and kept, excluding that obtained within 15 days before and 5 days after calving, or such longer period as may be necessary to render the milk practically colostrum free.
17. lappuse - Act upon removal from such processing, labeling, or repacking establishment. (b) (1) A drug intended for use by man which (A) is a habit-forming drug to which section 502 (d) applies; or (B) 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...
528. lappuse - HHS of Customs for its release and delivery to the importer; but if, upon such final re-examination by such board, the tea shall be found to be inferior in purity, quality, and fitness for consumption, as compared with the said standards, the importer or consignee shall...
12. lappuse - The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear on either the label or the labeling (including the invoice).
519. 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.
47. lappuse - (1) the term 'manufacture, preparation, propagation, compounding, or processing' shall include repackaging or otherwise changing the container, wrapper, or labeling of any drug package in furtherance of the distribution of the drug from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer; "(2) the term 'name...
13. lappuse - Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English. (2) If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language. (3) If the labeling contains any representation in a foreign language, all words, statements, and other information required by or under authority...
20. lappuse - An exemption of a shipment or other delivery of a cosmetic under paragraph (a) (2) of this section shall become void ab initio with respect to the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to make available for inspection a copy of the agreement, as required by such clause.
518. 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.
311. lappuse - ... (d) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21 unless otherwise noted.