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
... electronic 416 products .... 420 1005 Importation of electronic products . 422 1010 Performance standards for electronic products : General 426 1020 Performance standards for ionizing radiation emitting products .............. 431 1030 ...
... electronic 416 products .... 420 1005 Importation of electronic products . 422 1010 Performance standards for electronic products : General 426 1020 Performance standards for ionizing radiation emitting products .............. 431 1030 ...
Page 52
... electronic products , as defined in § 1000.3 of this chapter , shall comply with the reporting requirements of Part 1002 of this chapter . § 807.85 Exemption from premarket noti- fication . ( a ) A device is exempt from the pre- market ...
... electronic products , as defined in § 1000.3 of this chapter , shall comply with the reporting requirements of Part 1002 of this chapter . § 807.85 Exemption from premarket noti- fication . ( a ) A device is exempt from the pre- market ...
Page 125
... electronic equipment , shall be suitable for its in- tended purposes and shall be capable of producing valid results . Such equip- ment shall be routinely calibrated , in- spected , and checked according to written procedures . Records ...
... electronic equipment , shall be suitable for its in- tended purposes and shall be capable of producing valid results . Such equip- ment shall be routinely calibrated , in- spected , and checked according to written procedures . Records ...
Page 169
... electronic device intended to store , re- trieve , and process laboratory data . ( b ) Classification . Class I. § 862.2140 Centrifugal chemistry analyzer for clinical use . Identification 169 Food and Drug Administration , HHS § 862.2100.
... electronic device intended to store , re- trieve , and process laboratory data . ( b ) Classification . Class I. § 862.2140 Centrifugal chemistry analyzer for clinical use . Identification 169 Food and Drug Administration , HHS § 862.2100.
Page 249
... Electronic stethoscope— ( 1 ) Iden- tification . An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart , arteries , and veins and other in- ternal organs . ( 2 ) ...
... Electronic stethoscope— ( 1 ) Iden- tification . An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart , arteries , and veins and other in- ternal organs . ( 2 ) ...
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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...