scholarly journals Device or Device Component Manufacturing

2020 ◽  
Author(s):  
Keyword(s):  
Component Manufacturing ◽  
Device Component

scholarly journals New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions

2021 ◽  
Author(s):  
Nobuo Uemura ◽  
Hiroshi Kasanuki ◽  
Mitsuo Umezu
Keyword(s):  
The United States ◽  
New Combination ◽  
Biological Product ◽  
Regulatory Scheme ◽  
Early Access ◽  
Dimensional Group ◽  
Device Component ◽  
Intended Use ◽  
Component Function

Abstract Objective The developer and sponsor of new combination products in US needs to forecast which classification and designation to the regulatory scheme of drug, biological product, or device would be required for the new products by the Food and Drug Administration (FDA). To improve the predictability and acceptability of the designation of new combination products for innovators, developers, and sponsors, and to encourage the development and early access of new combination products, we proposed new visualization models of the designation pathway and group categorization. Method We searched the website of the FDA on 15 November, 2020 to identify the regulatory scheme of the FDA’s 129 capsular decision cases of device–drug and device–biologics combination products and other publicly available cases the FDA designated to the drug/biologic or device regulatory scheme. Results By introducing a new definition for primary intended use (PIU) by developers and sponsors extracted from the classification factors of primary mode of action (PMOA), we developed new visualization models of the designation pathway and two-dimensional group categorization. And applying these models to the cases the FDA designated, we proposed a new group categorization of combination products while focusing on the device component function. Conclusions The new visualization models with PIU and PMOA and the new group categorization focusing on the device component function proposed in this study may increase predictability and acceptability of the classification of newly developed combination products into the regulatory scheme of drug, biological product, and device, for innovators, developers, and sponsors.

CO2-laser based micro-machining for fiber component manufacturing

2021 ◽  
Author(s):  
Felix Wellmann ◽  
Michael Steinke ◽  
Mateusz Wysmolek ◽  
Peter Weßels ◽  
Ludger Overmeyer ◽  
...  
Keyword(s):  
Co2 Laser ◽  
Micro Machining ◽  
Component Manufacturing

Alloy 740H Component Manufacturing Development

2015 ◽  
pp. 203-210
Author(s):  
J.J. de Barbadillo ◽  
B.A. Baker ◽  
R.D. Gollihue ◽  
S.J. Patel
Keyword(s):  
Component Manufacturing

Yield Behavior of Tube Hydroforming and it’s Effecti on Hollow Component Manufacturing

2021 ◽  
Vol 871 ◽  
pp. 98-103
Author(s):  
Hong Yang Li ◽  
Hai Ping Deng ◽  
Song Yu
Keyword(s):  
Process Analysis ◽  
Tube Hydroforming ◽  
Yield Behavior ◽  
Component Manufacturing ◽  
Hollow Component

In this paper, aiming at the mechanics of tube hydroforming, the plasticity method was adopted in analyzing the stress yield behavior of the process. The stress character and yield behavior during the different stage of tube hydroforming was given and discussed. And then, basing on the discussing result, the yield behavior calculating formula was given and derived. At the same time, combining with the formula, figure of yield behavior was given. Base on the yield behavior character the process analysis was discussed in the end.

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