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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170. lappuse
... determine the safety of a device shall adequately demonstrate the absence of unreason- able risk of illness or injury associated with the use of the device for its in- tended uses and conditions of use . ( 2 ) Among the types of ...
... determine the safety of a device shall adequately demonstrate the absence of unreason- able risk of illness or injury associated with the use of the device for its in- tended uses and conditions of use . ( 2 ) Among the types of ...
247. lappuse
... determining in vitro susceptibility of bacterial patho- gens to these therapeutic agents . Test results are used to determine the anti- microbial agent of choice in the treat- ment of bacterial diseases . ( b ) Classification . Class II ...
... determining in vitro susceptibility of bacterial patho- gens to these therapeutic agents . Test results are used to determine the anti- microbial agent of choice in the treat- ment of bacterial diseases . ( b ) Classification . Class II ...
570. lappuse
... determine whether the facility is in compliance with this section and , if not , whether there is a need to notify affected patients , their physicians , or the public that the reliability , clarity , and accuracy of interpretation of ...
... determine whether the facility is in compliance with this section and , if not , whether there is a need to notify affected patients , their physicians , or the public that the reliability , clarity , and accuracy of interpretation of ...
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