Title:3D Printing – A Revolution in Modern Healthcare: Recent Achievements
& Challenges
Volume: 19
Issue: 3
Author(s): Anshul Chaudhary, Samiksha Sharma and Arti R. Thakkar*
Affiliation:
- Department of Drug Regulatory Affairs, Amity Institute of Pharmacy, Amity University Uttar Pradesh, Noida, 201313,
India
Keywords:
Spritam, medical devices, regulations, approvals, 3D printing, challenges.
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.
