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 vi
... listed in the Finding Aids at the end of this volume . What if the material incorporated by reference cannot be found ? If you have any problem locating or obtaining a copy of material listed in the Finding Aids of this volume as an ...
... listed in the Finding Aids at the end of this volume . What if the material incorporated by reference cannot be found ? If you have any problem locating or obtaining a copy of material listed in the Finding Aids of this volume as an ...
Page 3
... listing for manufacturers of devices .......... Exemptions from Federal preemption of State and local medical device requirements ............ In vitro diagnostic products for human use ...... Investigational device exemptions ...
... listing for manufacturers of devices .......... Exemptions from Federal preemption of State and local medical device requirements ............ In vitro diagnostic products for human use ...... Investigational device exemptions ...
Page 7
... listed below except to the extent that a product's manufacturer or packer has obtained an exemption from a packaging or la- beling requirement : ( 1 ) Initial effective date for packag- ing requirements . ( i ) The packaging requirement ...
... listed below except to the extent that a product's manufacturer or packer has obtained an exemption from a packaging or la- beling requirement : ( 1 ) Initial effective date for packag- ing requirements . ( i ) The packaging requirement ...
Page 9
... listed in § 5.115 of this chapter ) who is permitted by § 16.42 ( a ) of this chapter to preside over the hearing . ( 5 ) If the appellant requests a regu- latory hearing and requests that the hearing be held within 5 working days after ...
... listed in § 5.115 of this chapter ) who is permitted by § 16.42 ( a ) of this chapter to preside over the hearing . ( 5 ) If the appellant requests a regu- latory hearing and requests that the hearing be held within 5 working days after ...
Page 32
... listed in any order of frequency or severity . Reported adverse reactions include : endo- metritis , spontaneous abortion , septic abor- tion , septicemia , perforation of the uterus and cervix , embedment , fragmentation of the IUD ...
... listed in any order of frequency or severity . Reported adverse reactions include : endo- metritis , spontaneous abortion , septic abor- tion , septicemia , perforation of the uterus and cervix , embedment , fragmentation of the IUD ...
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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...