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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593. lappuse
... Records $ 1002.30 Records to be maintained by manufacturers . ( a ) Manufacturers of products listed under table 1 of §1002.1 shall establish and maintain the following records with respect to such products : ( 1 ) Description of the ...
... Records $ 1002.30 Records to be maintained by manufacturers . ( a ) Manufacturers of products listed under table 1 of §1002.1 shall establish and maintain the following records with respect to such products : ( 1 ) Description of the ...
719. lappuse
... records shall be ac- curate , indelible , and legible . The records shall identify the person per- forming the work , the dates of the var- ious entries , and shall be as detailed as necessary to provide a complete his- tory of the work ...
... records shall be ac- curate , indelible , and legible . The records shall identify the person per- forming the work , the dates of the var- ious entries , and shall be as detailed as necessary to provide a complete his- tory of the work ...
741. lappuse
... record , which is subject to the re- quirements of this section . All records must be accurate , indelible , and leg- ible . The records must identify the per- son performing the work and the dates of the various entries , and must be ...
... record , which is subject to the re- quirements of this section . All records must be accurate , indelible , and leg- ible . The records must identify the per- son performing the work and the dates of the various entries , and must be ...
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