FDA Issues Draft Guidance for 3D Printed Medical Devices

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 minutes
Product Description

Everything You Need to Know about FDA’s New Draft Guidance for 3D Printed Medical Devices

The US Food and Drug Administration (FDA) has released a new draft guidance for medical device manufacturers working with additive manufacturing (AM), which is more commonly known as 3D printing.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.

Session Highlights

  • Applicable Laws and Regulations
  • FDA Guidance
  • Definitions
  • Considerations for 3D Design and Manufacturing
  • Requirements for Process Validation
  • Considerations for Quality Data
  • Device Testing Requirements
  • Labeling
  • 3D Examples of Medical Devices
  • Speaker's PASS-IT Suggestions/Recommendation

Who should attend?

  • Healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • Compliance Officers
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Laboratory Personnel
  • R&D Professionals
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in this topic

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

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.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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