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 10
... operations or harm to the devices . ( ii ) To destroy the devices . ( iii ) To bring the devices into compli- ance . ( iv ) For any other purpose that the FDA representative who issued the de- tention order , or other responsible dis ...
... operations or harm to the devices . ( ii ) To destroy the devices . ( iii ) To bring the devices into compli- ance . ( iv ) For any other purpose that the FDA representative who issued the de- tention order , or other responsible dis ...
Page 45
... operation defined in § 807.3 ( c ) and not currently registered shall register the establishment by Oc- tober 22 , 1977 , and submit device list- ing by October 10 , 1978. An owner or operator of an establishment who has not previously ...
... operation defined in § 807.3 ( c ) and not currently registered shall register the establishment by Oc- tober 22 , 1977 , and submit device list- ing by October 10 , 1978. An owner or operator of an establishment who has not previously ...
Page 47
... operation defined in § 807.3 ( c ) shall be submitted on Form FD - 2891 ( a ) . This information shall be submitted within 30 days of such changes . Changes in the names of offi- cers and / or directors of the corporation ( s ) shall be ...
... operation defined in § 807.3 ( c ) shall be submitted on Form FD - 2891 ( a ) . This information shall be submitted within 30 days of such changes . Changes in the names of offi- cers and / or directors of the corporation ( s ) shall be ...
Page 68
... operation . ( iv ) Performance characteristics and specifications . ( v ) Operating instructions . ( vi ) Calibration procedures including materials and / or equipment to be used . ( vii ) Operational precautions and limitations ...
... operation . ( iv ) Performance characteristics and specifications . ( v ) Operating instructions . ( vi ) Calibration procedures including materials and / or equipment to be used . ( vii ) Operational precautions and limitations ...
Page 88
... operation of the device and any anticipated changes in the device that may occur in the course of the study in enough detail so that a scientist or physician familiar with the general type of lens can make a knowledgeable judgment about ...
... operation of the device and any anticipated changes in the device that may occur in the course of the study in enough detail so that a scientist or physician familiar with the general type of lens can make a knowledgeable judgment about ...
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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...