Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexSpecial 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 96.
37. lappuse
This includes contact when chapter , all testing data must be rethe device that
contains natural rubber tained in each company ' s files , and is connected to the
patient by a liquid shall be made available upon request path or an enclosed gas
...
This includes contact when chapter , all testing data must be rethe device that
contains natural rubber tained in each company ' s files , and is connected to the
patient by a liquid shall be made available upon request path or an enclosed gas
...
38. lappuse
18 Files and distributor records . 803 . 19 Exemptions ... 22 When not to file .
panel of the device packaging , the outside package , container or wrapper , and
the immediate device package , container , or wrapper . ( f ) Devices that have ...
18 Files and distributor records . 803 . 19 Exemptions ... 22 When not to file .
panel of the device packaging , the outside package , container or wrapper , and
the immediate device package , container , or wrapper . ( f ) Devices that have ...
39. lappuse
Under this part , device user facilities , importers , and manufacturers , as defined
in 8803 . 3 , must report deaths and serious injuries to which a device has or may
have caused or contributed , must establish and maintain adverse event files ...
Under this part , device user facilities , importers , and manufacturers , as defined
in 8803 . 3 , must report deaths and serious injuries to which a device has or may
have caused or contributed , must establish and maintain adverse event files ...
45. lappuse
18 Files and distributor records . ly relate the request to a reported event . All
verbal requests will be con( a ) User facilities , importers , and firmed in writing by
the agency . manufacturers shall establish and maintain MDR event files . All
MDR ...
18 Files and distributor records . ly relate the request to a reported event . All
verbal requests will be con( a ) User facilities , importers , and firmed in writing by
the agency . manufacturers shall establish and maintain MDR event files . All
MDR ...
46. lappuse
MDR event files must be maintained for the time periods de - scribed in this
paragraph even if the device is no longer distributed . ( d ) ( 1 ) A device
distributor shall establish and maintain device complaint records containing any
incident ...
MDR event files must be maintained for the time periods de - scribed in this
paragraph even if the device is no longer distributed . ( d ) ( 1 ) A device
distributor shall establish and maintain device complaint records containing any
incident ...
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accessories accordance amended amended at 65 ance standards application approval blood body cause Class II perform Classification clinical commercial distribution completion component consists container designed detention determine device intended device is exempt diagnosis disease effective electrical equipment established evaluation facility Federal files Food and Drug hearing human Identification implanted indicate joint labeling laser limits manufacturer material means measure ment monitor notice operation paragraph patient period person placed powered practice premarket notifica premarket notification procedures procedures in subpart prosthesis radiation reagents reasonable records regulation request respect safety Sept serum specific statement submitted subpart E surgical tended test system tion procedures tissue treatment trols tube unit unless vice x-ray
Populāri fragmenti
82. lappuse - label" means a display of written, printed, or graphic matter upon the immediate container of any article; 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 on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. (1) The...
20. lappuse - 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...
16. lappuse - 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. (3) If the labeling contains any representation in a foreign language, all words, statements, and other information required by or under authority...
22. lappuse - Except as provided by paragraphs (c) and (d) of this section, a shipment or other delivery of a food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling...
14. lappuse - 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).
575. lappuse - Electronic products intended for export. The performance standards prescribed in this subchapter shall not apply to any electronic product which is intended solely for export if: (a) Such product and the outside of any shipping container used in the export of such product are labeled or tagged to show that such product is intended for export...
22. lappuse - 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).
636. 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. (d) Condensed milk. Condensed milk, as the term is used in section 3, paragraph 2, of the Federal Import Milk Act...
18. lappuse - In the largest whole units (quarts, quarts and pints, or pints, as appropriate) with any remainder In terms of fluid ounces or common or decimal fractions of the pint or quart...
21. lappuse - Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented...
Bibliogrāfiskā informācija
| Nosaukums | Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and Index |
| Līdzstrādnieks | United States. Office of the Federal Register |
| Izdevējs | Division of the Federal Register, the National Archives, 2001 |
| Oriģināls no | Mičiganas universitāte |
| Digitalizēta | 22.6.2007 |
| Eksportēt avotu | BiBTeX EndNote RefMan |