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, 1999 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
No grāmatas satura
1.5. rezultāts no 100.
3. lappuse
... device listing for manufacturers and initial importers of devices ... Exemptions from Federal preemption of State and local medical device requirements In vitro diagnostic products for human use Medical device recall authority ...
... device listing for manufacturers and initial importers of devices ... Exemptions from Federal preemption of State and local medical device requirements In vitro diagnostic products for human use Medical device recall authority ...
21. lappuse
... device for which directions , hazards , warnings , and other informa- tion ... exempt at the time of delivery to the ultimate purchaser or user from sec ... device shall be exempt from sec- tion 502 ( f ) ( 1 ) of the act insofar as ade ...
... device for which directions , hazards , warnings , and other informa- tion ... exempt at the time of delivery to the ultimate purchaser or user from sec ... device shall be exempt from sec- tion 502 ( f ) ( 1 ) of the act insofar as ade ...
22. lappuse
... devices ; expiration of exemptions . ( a ) If a shipment or delivery , or any part thereof , of a device which is ex- empt under the regulations in this sec- tion is made to a person in whose pos- session the article is not exempt , or ...
... devices ; expiration of exemptions . ( a ) If a shipment or delivery , or any part thereof , of a device which is ex- empt under the regulations in this sec- tion is made to a person in whose pos- session the article is not exempt , or ...
45. lappuse
... device - related death , serious injury , or malfunction was or was not ... exempt from the reporting requirements under this part . ( 1 ) An individual ... device exemption regulations , parts 812 and 813 of this chapter , which require ...
... device - related death , serious injury , or malfunction was or was not ... exempt from the reporting requirements under this part . ( 1 ) An individual ... device exemption regulations , parts 812 and 813 of this chapter , which require ...
85. lappuse
... device to be in violation of any requirement applicable to the device under the act . ( 3 ) The Commissioner may not grant an application for an exemption from preemption for any requirement with respect to a device if the Commissioner ...
... device to be in violation of any requirement applicable to the device under the act . ( 3 ) The Commissioner may not grant an application for an exemption from preemption for any requirement with respect to a device if the Commissioner ...
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AC-powered accessories amended at 61 ance standards application blood cardiopulmonary bypass catheter chapter Class II perform Class III premarket Classification clinical clude commercial distribution Commissioner complaint files component Date PMA December 26 denture device intended device is exempt device that consists disease distributor Drug Administration effective date electronic emission equipment Federal fluid Food and Drug hearing aid ical Identification image receptor immunological test system implanted intended for medical intended to measure June 12 labeling laser laser product mammography manufac manufacturing practice market notification means medical purposes ment monitor notice of completion operation package paragraph patient PDP is required plasma PMA or notice premarket approval premarket notifica premarket notification procedures procedures in subpart prosthesis quirements radiation requirement for premarket requirements concerning records respect to complaint Sept serum specific submitted surgical tion procedures tissue trols tube type of device vice x-ray system
Populāri fragmenti
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...
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).
625. 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...
22. lappuse - An exemption of a shipment or other delivery of a cosmetic 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 clause.
568. lappuse - Exposure means the quotient of dQ by dm where dQ is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass dm are completely stopped in air.
19. lappuse - ... 158 sq inches (1 sq ft 14 sq in)." (o) Nothing in this section shall prohibit supplemental statements at locations other than the principal display panel(s-) describing in nondeceptive terms the net quantity of contents, provided that such supplemental statements of net quantity of contents shall not include any term qualifying a unit of weight, measure, or count that tends to exaggerate the amount of the drug contained in the package; for example, "giant pint
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 requirements of...
19. lappuse - Net wt. 24 oz. (1 Ib. 8 oz.)", "Net wt. 24 oz. (1% Ib.)", or "Net wt. 24 oz. (1.5 Ib.)". (2) A declaration of three-fourths pound avoirdupois weight shall be expressed as "Net wt. 12 oz.
420. lappuse - ... (d) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21 unless otherwise noted.