transitional devices used in classification

Found inside – Page 552... risk and to assure that all devices which are classified in the premarket approval category ( Class III ) are safe and effective for their intended use ... Found inside – Page 2Little or no attempt at formal classification has been made . Similar transitional devices are grouped together for purposes of description . The frequent union of several transitional elements in one passage and the difficulty of fixing hard and ... Found inside – Page 51761540-546 ( 21 proposed regulation to classify methyl or biting bone during ... is a class III transitional device BILLING CODE 4110-03 - M Effective date . Found inside – Page 331-25315 , Electric Lamp and Discharge Devices , Systems , subclass 137+ for ... of the transition type wherein a plural grid active element is utilized . Found inside – Page 244... of them were transitional devices , absorbable sutures were included as devices ... used to join parts of the body via the physical function of sewing . Found inside – Page 205By statute , these devices are automatically placed in class 3 instead of ... The transitional devices have not gone through the regular classification ... Found inside – Page 5Medical Devices, March 1936-March 1978 United States. ... exists to determine whether In identifying transitional devices it general controls or performance ... Found inside – Page 8... to initiate classification pro ceedings for all transitional devices and ... of constraints on the use of certain proprietary data in FDA's files . Found inside – Page 68/24/79 Proposal Classification of General Hospital and Personal Use Medical ... Three former products regulated as drugs ( transitional devices ) are also ... Found inside – Page 180In addition , FDA may be able to sponsor educational programs for device users ... Classification of transitional devices : As a first step in this process ... Found inside – Page 568MEDICAL DEVICES Publist proposed and final premarket approval procedural ... the device's potential risk and assure that all devices which are classified in ... Found inside – Page 738... risk and to assure that all devices which are classified in the premarket approval category ( Class III ) are safe and effective for their intended use ... Found inside – Page 476... standard for Class III device reclassified as Class II , 21 § 3600 Revision , requirements , 21 § 360e Transitional provisions for devices considered as new drugs or antibiotic drugs , 21 § 360j Classification of devices intended for human use ... Found inside – Page 334A device included in this part that is classified into class III ... be a “ new ” device as defined in this section because of any new intended use or other ... Found inside – Page 128... time devices B2560H Transition moments A3270C , A3370C Transition probabilities A3270F , A3370F Transition radiation ... C1340 Variational techniques A0230 , BO220 , B0260 , C1120 , C1180 Varistors B2120 , B2560Z Varnish B2830C ... Found inside – Page 279Account for all the parts in your division or classification. ... Whatever the number, don't forget to use transitional devices for easy movement from ... Found inside – Page 623Could you outline the specific use of $ 1.7 million you have requested for FY ... to actual design of facilities . classification of Transitional Devices ... This is the first book on multivariate analysis to look at large data sets which describes the state of the art in analyzing such data. Found inside – Page 569Assisted the 19 FDA classification advisory panels in publishing classification recommendations for ... As required by the transitional device provisions of ... Found inside – Page 1246... devices which are classified in the premarket approval category ( Class III ) are safe and effective for their intended use , in 1980 FDA will : Publish ... Found inside... for review and reclassification of pre - amendment class III devices ; a 15 FTE increase to revise the classification of transitional devices ; 41 FTEs ... Found inside – Page 68The transitional devices have not gone through the regular classification process. This has meant artificially high costs for manufacturers, ... Found inside – Page 1216Also in 1978 FDA is reviewing premarket requests for transitional devices ... at least 30 months after preamendment product classification , FDA wants to ... Found inside – Page 22There is no statutory duty to obtain an IDE unless use of a device for ... Congress also knew that FDA had begun preliminary device classification efforts ... Found inside – Page 84Any Class III transitional device is automatically classified into Class III and ... The use of such devices generally requires approval by an institutional ... Found inside – Page 738... that all devices which are classified in the premarket approval category ( Class III ) are safe and effective for their intended use , in 1982 FDA will ... Found inside – Page 2Little or no attempt at formal classification has been made . Similar transitional devices are grouped together for purposes of description . The frequent union of several transitional elements in one passage and the difficulty of fixing hard and ... Found inside – Page 265Subpart B - Diagnostic Devices 8 872.1500 Gingival fluid measurer . ... codify the statutory classification of the device into class III for such new use . Found inside – Page 872Publish final classification regulations for devices covered by nine of the 16 ... of inequivalent ( Class III ) devices or transitional devices . Found inside – Page 872Publish final classification regulations for devices covered by nine of the 16 ... of inequivalent ( Class III ) devices or transitional devices . Found inside – Page 122Some members of March 1984 ( 108 ) and May 1987 the device industry have con ... was a " transitional " device that would automatically be classified in ... Found inside – Page 394classification of the device into class III for such new use . ... Accordingly , the regulation for such a class III transitional device states that as of ... Found inside... Pathways The 510(k) Pathway Most devices used by orthopaedic surgeons are ... III transitional devices and new devices are classified automatically as ... Found insideThe final rule includes the statutory classification , however , of two transitional devices not included in the 1982 proposal . ( Transitional devices are ... Found inside – Page 872Publish final classification regulations for devices covered by nine of the 16 ... 40 premarket approval applications ( PMAS ) for transitional devices . Found inside – Page 279Account for all the parts in your division or classification. ... Whatever the number, don't forget to use transitional devices for easy movement from ... Found inside – Page 591A device included in this part that is classified into class III ... be a ''new'' device as defined in this section because of any new intended use or other ... Found inside – Page 279Account for all the parts in your division or classification. ... Whatever the number, don't forget to use transitional devices for easy movement from ... Found inside – Page 569classification recommendations for all devices as required by the 1976 Device ... for reclassification of new ( inequivalent ) or transitional devices . Found inside – Page 1325Classification of , devices intended for human use , generally , ante , this heading ... 21 § 360 New drugs , transitional provisions applicable for devices ... Found inside – Page 585-6Using transition metal oxide , sulfide , or salt . ... flow procedure within or at entrance to reactor , e.g. , by use of named mixing device , etc. Found inside – Page 28It also contained a list of products that FDA would regulate as transitional devices and a separate list of products that would be classified into class I ... Found inside – Page 7The first of these exemptions were granted in the final classification regulations for general hospital and personal use devices . Found inside – Page 253A device included in this part that is classified into class III ... be a “ new ” device as defined in this section because of any new intended use or other ... Found inside – Page 67The process by which these devices were classified began with the ... covers the conditions of use for the device , other persons for whose use the device ...