The US Food and Drug Administration (FDA) has released a new draft guidance for medical device manufacturers working with additive manufacturing (AM), which is more commonly known as 3D printing. In March, FDA approved the first-ever 3D printed drug, Aprecia's epilepsy drug SPRITAM, which relies on 3D printing technology to rapidly disintegrate in a patient's mouth, making it easier to swallow. For biologics, researchers are looking into 3D printing as a means of manufacturing cell and tissue products.
Join expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, in this power packed Live Conference which intends to discuss technical considerations while designing, developing and manufacturing 3D printed medical devices. In particular, it is intended to present FDA’s current views and perspectives on technical challenges, considerations and assessments relevant and applicable for 3D medical products (e.g., medical devices).
This presentation will provide great opportunities to become aware of and get familiar with FDA’s perspectives on 3D printing. In this conference, the speaker will discuss what firms should consider and address to expedite FDA’s process of evaluating 3D products in regulatory submissions.
Who should attend?
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.