Abstract
The pharmaceutical industry grows every year keeping public health as a priority, protection, and economic development. The industry is mostly concentrated on the novel drug development process as well as new methods that can help improve the recovery rate of a condition and improve the quality of patient treatment. Pharmaceutical companies have recently experimented with producing medications using 3D printing to increase their quality and improve user health. Later, in 2015, the companies found success by producing the 3D-printed medication Spritam, which had already received US FDA approval. Over the past few years, the medical device industry has adapted to 3D printing technology and creative companies have used it to produce goods with distinctive content, appearance, and customizability. However, these distinctive capabilities of 3D printing have brought forth new legal difficulties and troubling issues with the regulatory agencies' acceptance of these devices. Customizability and distinctive construction procedures of medical devices printed via 3D printing techniques have difficulties in attaining quality assurance and regulatory criteria for manufacturing. Advancement in 3D printing technology has helped in the production of various innovative medical products along with new structures and constituents. The present review discusses distinctive regulatory problems faced by the USFDA as well as by other regulatory authorities in the case of approval of 3D printing products and measures required to develop regulations for the safety, quality, and effectiveness of 3D printing Devices.
Graphical Abstract
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