Compilation of Selected Acts Within The Jurisdiction of The Committee on Energy and Commerce, March 2005, 109-1 Committee Print 109-A, *2005 |
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Page 13
... device " means a device that is in- tended for one use , or on a single patient during a single procedure . ( 2 ) ( A ) The term " reprocessed " , with respect to a single - use de- vice , means an original device that has previously ...
... device " means a device that is in- tended for one use , or on a single patient during a single procedure . ( 2 ) ( A ) The term " reprocessed " , with respect to a single - use de- vice , means an original device that has previously ...
Page 110
... device classified under section 513 ( f ) into class III and intended solely for investigational use , paragraph1 ( 1 ) ( B ) shall not apply with respect to such device during the period ending on the ninetieth day after the date of ...
... device classified under section 513 ( f ) into class III and intended solely for investigational use , paragraph1 ( 1 ) ( B ) shall not apply with respect to such device during the period ending on the ninetieth day after the date of ...
Page 115
... device and there was a failure or refusal ( 1 ) to com- ply with any requirement prescribed under section 518 respecting the device , ( 2 ) to furnish any material or information required by or under section 519 respecting the device ...
... device and there was a failure or refusal ( 1 ) to com- ply with any requirement prescribed under section 518 respecting the device , ( 2 ) to furnish any material or information required by or under section 519 respecting the device ...
Page 176
... device shall be the only official name of that drug or device used in any official compendium published after such name has been prescribed or for any other purpose of this Act . In no event , however , shall the Secretary establish an ...
... device shall be the only official name of that drug or device used in any official compendium published after such name has been prescribed or for any other purpose of this Act . In no event , however , shall the Secretary establish an ...
Page 179
... devices and a brief statement of the basis for believing that each device included in the list is a device rather than a drug ( with each drug and device in each list listed by its established name ( as defined in section 502 ( e ) ...
... devices and a brief statement of the basis for believing that each device included in the list is a device rather than a drug ( with each drug and device in each list listed by its established name ( as defined in section 502 ( e ) ...
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Common terms and phrases
action active ingredient amendment animal drug application animal feed appropriate approved new animal Attorney authorized bioequivalence cation certification classification clause clause iv clinical containing controlled substance court described dispensing distribution dosage form drug or device drug product ecgonine electronic product enactment established exemption expiration Federal Food Federal Register filed fiscal Food and Drug graph Health Service Act infant formula investigational issued labeling licensed listed chemical listed drug manufacturer ment notice notification panel paragraph patent period person pesticide petition phenylpropanolamine premarket prescribed proposed pseudoephedrine Public Law purposes referred registration regulation request respect retary route of administration safety and effectiveness safety or effectiveness schedule III Secretary determines Secretary finds section 351 sentence specified spect standard subchapter subclause submitted subparagraph substance in schedule supplement term of imprisonment tion United States Code United States Pharmacopoeia unless violation