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 4
... Importation of electronic products . 422 1010 Performance standards for electronic products : General 426 1020 ... Importation Act ............ Regulations under the Federal Caustic Poison Act Control of communicable diseases Interstate ...
... Importation of electronic products . 422 1010 Performance standards for electronic products : General 426 1020 ... Importation Act ............ Regulations under the Federal Caustic Poison Act Control of communicable diseases Interstate ...
Page 24
... importer for resale . Such importer may have the tests required by para- graph ( d ) of this section conducted in the country of origin but must make the results thereof available , upon re- quest , to the Food and Drug Adminis- tration ...
... importer for resale . Such importer may have the tests required by para- graph ( d ) of this section conducted in the country of origin but must make the results thereof available , upon re- quest , to the Food and Drug Adminis- tration ...
Page 36
... importer to report to FDA whenever the manufacturer or import- er receives or otherwise becomes aware of information that reasonably sug- gests that one of its marketed devices ( 1 ) may have caused or contributed to a death or serious ...
... importer to report to FDA whenever the manufacturer or import- er receives or otherwise becomes aware of information that reasonably sug- gests that one of its marketed devices ( 1 ) may have caused or contributed to a death or serious ...
Page 37
... importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur . ( h ) A " serious injury " is an injury that ( 1 ) is life threatening , ( 2 ) results in permanent impairment of a body ...
... importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur . ( h ) A " serious injury " is an injury that ( 1 ) is life threatening , ( 2 ) results in permanent impairment of a body ...
Page 38
... importer shall report to FDA by telephone as soon as possible , but no later than within 5 calendar days of initial receipt of the information . The manufacturer or im- porter shall include in the telephone report the information listed ...
... importer shall report to FDA by telephone as soon as possible , but no later than within 5 calendar days of initial receipt of the information . The manufacturer or im- porter shall include in the telephone report the information listed ...
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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...