The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1988 - Administrative law 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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Page 35
... files . 803.33 Where to submit a report . 803.36 Exemptions from reporting . AUTHORITY : Secs . 502 ( t ) , 510 , 519 , 701 ( a ) , 704 ( a ) and ( e ) , 52 Stat . 1055 , 76 Stat . 792- 795 as amended , 90 Stat . 564-565 , 578 35 Food ...
... files . 803.33 Where to submit a report . 803.36 Exemptions from reporting . AUTHORITY : Secs . 502 ( t ) , 510 , 519 , 701 ( a ) , 704 ( a ) and ( e ) , 52 Stat . 1055 , 76 Stat . 792- 795 as amended , 90 Stat . 564-565 , 578 35 Food ...
Page 36
... file , and the require- ments under § 820.180 that a manufac- turer allow access to , and copying of , these files by any authorized FDA rep- resentative . ( c ) References in this part to regula- tory sections of the Code of Federal ...
... file , and the require- ments under § 820.180 that a manufac- turer allow access to , and copying of , these files by any authorized FDA rep- resentative . ( c ) References in this part to regula- tory sections of the Code of Federal ...
Page 40
... files . ( a ) An importer shall establish a complaint file and maintain a record of any information , including any written or oral communication , re- ceived by the importer concerning a death , serious injury , or device mal- function ...
... files . ( a ) An importer shall establish a complaint file and maintain a record of any information , including any written or oral communication , re- ceived by the importer concerning a death , serious injury , or device mal- function ...
Page 46
... file maintained by the initial distributor . ( 2 ) For those imported devices for which the initial distributor repack- ages or relabels the device , form FD- 2892 shall be submitted and the histor- ical file maintained by the initial ...
... file maintained by the initial distributor . ( 2 ) For those imported devices for which the initial distributor repack- ages or relabels the device , form FD- 2892 shall be submitted and the histor- ical file maintained by the initial ...
Page 48
... file any la- beling or advertisements in which a material change has been made any- time after initial listing . ( c ) Each owner or operator may dis- card labeling and advertisements from the historical file 3 years after the date of ...
... file any la- beling or advertisements in which a material change has been made any- time after initial listing . ( c ) Each owner or operator may dis- card labeling and advertisements from the historical file 3 years after the date of ...
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Common terms and phrases
52 Stat 90 Stat accessories ance standards application blood bone cement Cardiopulmonary bypass catheter cation chapter Class II perform Class III premar Classification clinical clude commercial distribution Commissioner complaint files compliance component contact lens controls current good manufacturing Date PMA denture device intended device is exempt device that consists disease Drug Administration effective date emission equipment established Federal Food and Drug Health hearing aid Identification immunological test system implanted intended for medical intended to measure intraocular lens investigational study 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 person plasma PMA or notice practice regulations premarket approval prosthesis quirements concerning records radiation reagents request respect to complaint section 515 serological serum specific sponsor statement submitted tion tube type of device x-ray system
Popular passages
Page 496 - 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.
Page 20 - A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which "adequate directions for use...
Page 16 - 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.
Page 497 - 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.
Page 22 - An exemption of a shipment or other delivery of a device 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 paragraph (ax 2).
Page 14 - 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).
Page 46 - (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...
Page 345 - ... (d) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21 unless otherwise noted.
Page 496 - 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.
Page 18 - The declaration shall be expressed both in ounces, with identification by weight or by liquid measure and, if applicable (1 pound or 1 pint or more) followed in parentheses by a declaration in pounds for weight units, with any remainder in terms of ounces or common or decimal fractions of the pound...