Code of Federal Regulations 21 Parts 800 to 1299 Food and Drugs: Revised as of April 1 2006U.S. Government Printing Office, 2006 - 796 lappuses The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the United States Federal Government. This volumwe contains the regulations about medical devices. |
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1.–3. rezultāts no 90.
66. lappuse
... drug . ( 7 ) For a device that the owner or op- erator has manufactured for distribu- tion under a label other than ... Food and Drug Ad- ministration , pursuant to part 607 of this chapter ; drug products shall be listed with the Center for ...
... drug . ( 7 ) For a device that the owner or op- erator has manufactured for distribu- tion under a label other than ... Food and Drug Ad- ministration , pursuant to part 607 of this chapter ; drug products shall be listed with the Center for ...
91. lappuse
... Food and Drug Administration as accurate and reliable for the testing of such speci- mens for identifying drugs of abuse or their metabolites . ( c ) The laboratory performing the test ( s ) shall have , and shall be recog- nized as ...
... Food and Drug Administration as accurate and reliable for the testing of such speci- mens for identifying drugs of abuse or their metabolites . ( c ) The laboratory performing the test ( s ) shall have , and shall be recog- nized as ...
181. lappuse
... Food and Drug Administra- tion will establish advisory commit- tees to which proposed regulations may be referred , and these committees shall consider such referrals in accordance with this section and part 14 of this chapter . Such ...
... Food and Drug Administra- tion will establish advisory commit- tees to which proposed regulations may be referred , and these committees shall consider such referrals in accordance with this section and part 14 of this chapter . Such ...
Saturs
1 For nomenclature changes to chapter I see 59 FR 14366 Mar 28 1994 | 3 |
Labeling | 13 |
Medical device reporting | 38 |
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AC-powered accessories accreditation body amended at 65 ance standards application blood cardiopulmonary bypass catheter chapter subject Class II perform Class II special Classification clinical clude commercial distribution complaint files component current good manufacturing Date PMA dental denture device intended device is exempt device that consists disease electronic equipment facility FDA's fluoroscopic Food and Drug guidance document Identification image receptor immunological test system implanted intended for medical intended to measure July 25 labeling limitations mammography manufacturing practice manufacturing practice regula means medical purposes ment monitor notice of completion paragraph patient PDP is required plasma PMA or notice postmarket surveillance premarket approval premarket notification procedures procedures in subpart prosthesis radiation reagents regulation requirements concerning records respect to complaint Sept serological serum special controls specific submit subpart E surgical tion tissue trols type of device vice x-ray system