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
1.–3. rezultāts no 89.
44. lappuse
... Submit reports of device - related deaths to us and to the manufacturer , if known ; or ( ii ) Submit reports of device - related serious injuries to the manufacturers or , if the manufacturer is unknown , submit reports to us . ( 2 ) ...
... Submit reports of device - related deaths to us and to the manufacturer , if known ; or ( ii ) Submit reports of device - related serious injuries to the manufacturers or , if the manufacturer is unknown , submit reports to us . ( 2 ) ...
45. lappuse
... submit reports in English ? ( a ) Yes . You must submit all written or electronic equivalent reports re- quired by this part in English . ( b ) If you submit any reports re- quired by this part in an electronic me- dium , that submission ...
... submit reports in English ? ( a ) Yes . You must submit all written or electronic equivalent reports re- quired by this part in English . ( b ) If you submit any reports re- quired by this part in an electronic me- dium , that submission ...
162. lappuse
... submission and submit it to us within the specified timeframe . We will determine the timeframe case- by - case , based on the types of re- visions or information that you must submit Revise your postmarket surveillance submission and ...
... submission and submit it to us within the specified timeframe . We will determine the timeframe case- by - case , based on the types of re- visions or information that you must submit Revise your postmarket surveillance submission and ...
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