Amar S, Balamuralidhara V, T M Pramod Kumar
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Amar S1, Balamuralidhara V2, T M Pramod Kumar3
1Regulatory Affairs Group, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysore – 570015, Karnataka, India.
2Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysore – 570015, Karnataka, India.
3Principal, Department of Pharmaceutics, JSS College of Pharmacy, S.S.Nagara, Mysuru – 570015.
Volume - 14,
Issue - 3,
Year - 2021
From past several decades 3D printing technology has quickly came into the medical device sector and has been exploited by creative organization to produce products with distinctive composition, structure, and customizability. These distinguishing skills that 3D printing has created fresh regulatory difficulties. 3D printed devices customizability presents fresh Implications when developing an FDA market approval model for design control. The customizability and distinctive construction procedures of 3D printed medical devices present special difficulties in meeting the quality assurance of production regulatory standards. In order to guarantee a quality construction, reliable objects powder characteristics then Ideal parameters for printing such as construction orientation and laser energy should discussed later conveyed to FDA. Also addressed are post-printing factors that are special to three dimensional printed devices, like sterilization cleaning, and finishing. It will lead a controlled output and continuous device production by Use of the same quality control and design policies used to conventional built-up techniques with three-dimensional printing. The advancement of 3D printing technology has produced innovative medical devices with a new structure and constituents. This research shows the distinctive regulatory problems facing USFDA consideration to the device plan growth, production, sterilization and biocompatibility.
Cite this article:
Amar S, Balamuralidhara V, T M Pramod Kumar. Manufacturing and Designing of Implantable 3D-Printed Medical Devices - An Overview of Regulatory Challenges. Research J. Pharm. and Tech 2021; 14(3):1785-1790. doi: 10.5958/0974-360X.2021.00317.6
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