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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548. lappuse
... body that does not plan to renew its approval shall so notify FDA at the address given in paragraph ( b ) ( 1 ) of this section at least 9 months before the expiration of the body's term of approval . ( d ) Rulings on applications for ...
... body that does not plan to renew its approval shall so notify FDA at the address given in paragraph ( b ) ( 1 ) of this section at least 9 months before the expiration of the body's term of approval . ( d ) Rulings on applications for ...
551. lappuse
... body shall be reviewed independently by two For more review physicians . ( 4 ) Selection of clinical images for re- view . Unless otherwise specified by FDA , the accreditation body shall re- quire that for each mammography unit in the ...
... body shall be reviewed independently by two For more review physicians . ( 4 ) Selection of clinical images for re- view . Unless otherwise specified by FDA , the accreditation body shall re- quire that for each mammography unit in the ...
554. lappuse
... body ; ( 2 ) Maintain a record of every serious unresolved complaint received by the body on all facilities it accredits for a period of at least 3 years from the date of receipt of each such complaint ; ( h ) Reporting and ...
... body ; ( 2 ) Maintain a record of every serious unresolved complaint received by the body on all facilities it accredits for a period of at least 3 years from the date of receipt of each such complaint ; ( h ) Reporting 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