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 32
... implantation of the fertilized egg in the lining of the uterine cavity . The IUD does not prevent ovulation . The effectiveness of the IUD is measured by the pregnancy rate of women who use it and the rate of adverse reactions and side ...
... implantation of the fertilized egg in the lining of the uterine cavity . The IUD does not prevent ovulation . The effectiveness of the IUD is measured by the pregnancy rate of women who use it and the rate of adverse reactions and side ...
Page 42
... implanted during the procedure about which the report is being made : the name of the manufacturer , model number , serial number , and the warranty expiration date . ( h ) For each device ( pulse generator , atrial lead , ventricular ...
... implanted during the procedure about which the report is being made : the name of the manufacturer , model number , serial number , and the warranty expiration date . ( h ) For each device ( pulse generator , atrial lead , ventricular ...
Page 83
... implanted or where records of results from use of devices are kept ) . ( b ) Records inspection . A sponsor , IRB , or investigator , or any other person acting on behalf of such a person with respect to an investiga- tion , shall ...
... implanted or where records of results from use of devices are kept ) . ( b ) Records inspection . A sponsor , IRB , or investigator , or any other person acting on behalf of such a person with respect to an investiga- tion , shall ...
Page 95
... implanting the lens are adequate to assure the device will be tested under conditions that adequately assure the ... implanted . The sponsor shall suspend the study and take such other action as soon as possible but in no event later ...
... implanting the lens are adequate to assure the device will be tested under conditions that adequately assure the ... implanted . The sponsor shall suspend the study and take such other action as soon as possible but in no event later ...
Page 104
... implanted . ( c ) Any investigator shall permit an authorized employee of the Food and Drug Administration to copy records that identify the names of human sub- jects , upon notice that the Food and Drug Administration has reason to be ...
... implanted . ( c ) Any investigator shall permit an authorized employee of the Food and Drug Administration to copy records that identify the names of human sub- jects , upon notice that the Food and Drug Administration has reason to be ...
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Common terms and phrases
accessories ance standards antibodies application ation blood bone cement Cardiopulmonary bypass catheter Class II perform Class III premar Classification clinical clude commercial distribution Commissioner complaint files component contact lens 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 equipment Federal fluid Food and Drug hearing aid hemoglobin Identification image receptor immunological test system implanted intended for medical intended to measure intraocular lens ket approval labeling laser laser product lens manufacturing practice means medical purposes ment for premarket monitor notice of completion operation ophthalmic paragraph patient PDP is required plasma PMA or notice practice regulation premarket approval prosthesis quirements concerning records reagents respect to complaint safety section 515 serological serological reagents serum specific sponsor submitted tion tissue tube type of device ultrasonic x-ray system
Popular passages
Page 494 - 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 495 - 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 494 - 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...