Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexDivision of the Federal Register, the National Archives, 1996 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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1.–5. rezultāts no 94.
7. lappuse
... Sept. 16 , 1983 , stayed the effective date of §800.12 ( f ) ( 3 ) until further notice . $ 800.20 Patient examination gloves and surgeons ' gloves ; sample plans and test method for leakage defects ; adulteration . ( a ) Purpose . The ...
... Sept. 16 , 1983 , stayed the effective date of §800.12 ( f ) ( 3 ) until further notice . $ 800.20 Patient examination gloves and surgeons ' gloves ; sample plans and test method for leakage defects ; adulteration . ( a ) Purpose . The ...
56. lappuse
... Sept. 14 , 1984 , unless ise noted . Subpart A - General Provisions 803.1 Scope . ( a ) FDA is requiring a device manufacturer or importer to report to FDA whenever the manufacturer or importer receives or other- wise becomes aware of ...
... Sept. 14 , 1984 , unless ise noted . Subpart A - General Provisions 803.1 Scope . ( a ) FDA is requiring a device manufacturer or importer to report to FDA whenever the manufacturer or importer receives or other- wise becomes aware of ...
59. lappuse
... Sept. 14 , 1984 , as amended at 49 FR 48273 , Dec. 12 , 1984 ] §803.31 Complaint files . ( a ) An importer shall establish a complaint file and maintain a record of any informa- tion , including any written or oral commu- nication ...
... Sept. 14 , 1984 , as amended at 49 FR 48273 , Dec. 12 , 1984 ] §803.31 Complaint files . ( a ) An importer shall establish a complaint file and maintain a record of any informa- tion , including any written or oral commu- nication ...
60. lappuse
... Sept. 1 , 1993 , unless otherwise noted . Subpart A - General Provisions §804.1 Scope . ( a ) FDA is requiring medical device distributors to report deaths , serious illnesses , and serious injuries that are attributed to medical ...
... Sept. 1 , 1993 , unless otherwise noted . Subpart A - General Provisions §804.1 Scope . ( a ) FDA is requiring medical device distributors to report deaths , serious illnesses , and serious injuries that are attributed to medical ...
69. lappuse
... Sept. 1 , 1993 ; 59 FR 64295 , Dec. 14 , 1994 ; 60 FR 63606 , Dec. 11 , 1995 ] EFFECTIVE DATE NOTE : At 60 FR 63606 , Dec. 11 , 1995 , §807.3 was amended by adding para- graph ( r ) , effective April 11 , 1996 . Subpart B - Procedures ...
... Sept. 1 , 1993 ; 59 FR 64295 , Dec. 14 , 1994 ; 60 FR 63606 , Dec. 11 , 1995 ] EFFECTIVE DATE NOTE : At 60 FR 63606 , Dec. 11 , 1995 , §807.3 was amended by adding para- graph ( r ) , effective April 11 , 1996 . Subpart B - Procedures ...
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acid amended at 54 ance standards antibodies application cardiopulmonary bypass catheter chapter Class II perform Class III premarket Classification cluding commercial distribution Commissioner complaint files Date PMA denture device intended device is exempt device that consists diagnosis and treatment distributor Drug Administration effective date established Federal Food Food and Drug hearing aid hemoglobin immunological test system implanted intended to measure intraocular lens inves investigational study June 12 labeling lens manufacturing practice medical device ment monitor notice of completion pacemaker package panel paragraph patient PDP is required petition plasma PMA or notice premarket approval premarket notifica premarket notification procedures procedures in Subpart protein reagents reagents are devices reclassification request requirement for premarket safety and effectiveness Sept serological serological reagents serum sponsor statement submitted surgical test sys tigational tion procedures tissue trols tube urine user facility vice
Populāri fragmenti
561. lappuse - That all charges for storage, cartage and labor on goods which are refused admission or delivery shall be paid by the owner or consignee, and in default of such payment shall constitute a...
15. lappuse - The failure of the label to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information; (4) Insufficiency of label space for the prominent placing of such word, statement, or information, resulting from the use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label; (5) Insufficiency of label...
21. lappuse - Act (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling, or repacking establishment.
98. lappuse - An identifying lot or control number from which it is possible to determine the complete manufacturing history of the package of the drug...
546. lappuse - 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.
60. lappuse - ... permit any authorized FDA employee at all reasonable times to have access to, and to copy and verify, the records contained in this file.
549. lappuse - Administration designated in the notice and shall be private and confined to questions of fact. The parties notified may present evidence, either oral or written, in person or by attorney, to show cause why the matter should not be referred for prosecution as a violation of the Federal Caustic Poison Act.
52. lappuse - ... similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; (2) shall define the term "serious injury...
94. lappuse - label" means a display of written, printed, or graphic matter upon the immediate container of any substance; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears...
83. lappuse - Except as provided in subsection (b), no State or political subdivision of a State may establish or continue in effect...