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. |
No grāmatas satura
324. lappuse
... completion of a PDP is required . No effective date has been established of the requirement for premarket approval . See § 870.3 . [ 45 FR 7907-7971 , Feb. 5 , 1980 , as amended at 52 FR 17737 , May 11 , 1987 ] § 870.5225 External ...
... completion of a PDP is required . No effective date has been established of the requirement for premarket approval . See § 870.3 . [ 45 FR 7907-7971 , Feb. 5 , 1980 , as amended at 52 FR 17737 , May 11 , 1987 ] § 870.5225 External ...
343. lappuse
... completion of a PDP is required . A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Adminis- tration on or before March 30 , 1999 , for any total temporomandibular joint prosthesis that was in ...
... completion of a PDP is required . A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Adminis- tration on or before March 30 , 1999 , for any total temporomandibular joint prosthesis that was in ...
364. lappuse
... completion of PDP is required . A PMA or a notice of completion of a PDP for a device is re- quired to be filed with the Food and Drug Administration on or before July 13 , 1999 for any suction antichoke de- vice that was in commercial ...
... completion of PDP is required . A PMA or a notice of completion of a PDP for a device is re- quired to be filed with the Food and Drug Administration on or before July 13 , 1999 for any suction antichoke de- vice that was in commercial ...
Saturs
1 For nomenclature changes to chapter I see 59 FR 14366 Mar 28 1994 | 3 |
Labeling | 13 |
Medical device reporting | 38 |
39 citas sadaļas nav parādītas.
Citi izdevumi - Skatīt visu
Bieži izmantoti vārdi un frāzes
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