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, 1983 |
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1.–5. rezultāts no 37.
5. lappuse
... package , so as to afford adequate directions and nec- essary warnings to minimize the hazard of injury resulting ... packages , there is the opportunity for the malicious adulteration of these products with risks both to individuals who ...
... package , so as to afford adequate directions and nec- essary warnings to minimize the hazard of injury resulting ... packages , there is the opportunity for the malicious adulteration of these products with risks both to individuals who ...
6. lappuse
... package . Each manufacturer and packer who packages for retail sale a product regulated as a medical device that is ... package the product in a tamper - resistant package . A tamper- resistant package is one having an in- dicator or ...
... package . Each manufacturer and packer who packages for retail sale a product regulated as a medical device that is ... package the product in a tamper - resistant package . A tamper- resistant package is one having an in- dicator or ...
11. lappuse
... package form shall specify conspicuously the name and place of business of the manufacturer , packer , or ... packages , the ZIP Code shall appear on either the label or the labeling ( including the invoice ) . ( e ) If a person ...
... package form shall specify conspicuously the name and place of business of the manufacturer , packer , or ... packages , the ZIP Code shall appear on either the label or the labeling ( including the invoice ) . ( e ) If a person ...
13. lappuse
... package form and as used in this part , means the part of a label that is most likely to be displayed , pre- sented ... packages bear alternate principal display panels , information required to be placed on the principal display panel ...
... package form and as used in this part , means the part of a label that is most likely to be displayed , pre- sented ... packages bear alternate principal display panels , information required to be placed on the principal display panel ...
14. lappuse
... package , the area shall con- sist of the entire top surface . In determining the area of the princi- pal display panel , exclude tops , bot- toms , flanges at the tops and bottoms of cans , and shoulders and necks of bottles or jars ...
... package , the area shall con- sist of the entire top surface . In determining the area of the princi- pal display panel , exclude tops , bot- toms , flanges at the tops and bottoms of cans , and shoulders and necks of bottles or jars ...
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52 Stat 90 Stat accessible emission limits amended ance standards antibodies antigens application ation blood Cardiopulmonary bypass catheter cell centimeters chapter Class II perform Class III premar Classification clude Commissioner compliance components container controls designed determine device intended device is exempt device that consists diagnostic Drug Administration effective electrical electronic product equipment exposure Federal Register fluid fluoroscopic Food and Drug Health hearing aid hemoglobin human image receptor immunological test system intended for medical intraocular lens investigational study ket approval labeling laser product lens manufac manufacturer manufacturing practice means medical device medical purposes ment monitor nanometers Office operation package panel paragraph patient person platelet premarket notification procedures quirements radiation reagents are devices records regulation requirements safety Secs Sept serological reagents serum Service specific spect sponsor statement submitted Subpart tion tissue tube type of device ultrasonic x-ray system x-ray tube
Populāri fragmenti
261. lappuse - Secretary or any officer or employee under his control, from the duly authorized committees of the Congress.
78. lappuse - Secretary's order. (i) The Secretary Shall promulgate regulations for exempting from the operation of the foregoing subsections of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.
114. lappuse - III (premarket approval), depending upon the level of regulatory control required to provide reasonable assurance of the safety and effectiveness of the device (§860.3(c)). This subpart does not apply to a device that is classified into class III by statute under section 513(f) of the act because the Food and Drug Administration has determined that the device is not "substantially equivalent...
273. lappuse - Hearing. (a) If it appears that the article may be subject to refusal of admission, the district director shall give the owner or consignee a written notice to that effect, stating the reasons therefor. The notice shall specify a place and a period of time during which the owner or consignee shall have an opportunity to introduce testimony. Upon timely request, giving reasonable grounds therefor, such time and place may be changed. Such testimony shall be confined to matters relevant to the admissibility...
346. lappuse - Secretary of the Treasury, and if such board shall, after due examination, find the tea in question to be equal in purity, quality, and fitness for consumption to the...
335. lappuse - Milk is the fresh, clean, lacteal secretion obtained by the complete milking of one or more healthy cows, properly fed and kept, excluding that obtained within fifteen days before and...
19. lappuse - If a shipment or delivery, or any part thereof, of a drug or device which is exempt under the regulations in this section is made to a person in whose possession the article is not exempt, or is made for any purpose other than those specified, such exemption shall expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery.
140. lappuse - Values for mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC) were calculated with standard equations using the determined values for hematocrit, hemoglobin, and RBC.
48. lappuse - Except as provided in subsection (b), no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement— (1) which is different from, or in addition to, any requirement applicable under this...
261. lappuse - Secretary or his representative pursuant to this subsection which information contains or relates to a trade secret or other matter referred to in section 1905 of title 18 of the United States Code, shall be considered confidential for the purpose of that section, except that such information may be disclosed to other officers or employees concerned with carrying out this Act or when relevant in any proceeding under this Act.