May 8-11, 2017 | David L. Lawrence Convention Center | Pittsburgh, Pennsylvania | Exhibits May 9-11

How to Get FDA Approvals for Your Additive Manufacturing Device

Medical Manufacturing Innovations (MMI) Program MMI: Quality, Regulatory & Implants

Expert May 10, 2017 2:45 pm - 3:10 pm

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Satya Patloori, Managing Director Life Sciences and Healthcare, Deloitte LLP
Reggie George, VP, Quality Systems, Johnson & Johnson

AM is making its presence in the health sector with benefits such as patient-matched devices, drug and disease testing, just-in-time inventory, and minimal material waste. It is not a matter of if AM will disrupt the healthcare landscape, it is a matter of when.

  • The FDA has approved over 85 3D-printed medical devices. Currently, the FDA regulates 3D-printed medical devices and medications the same way it regulates other medical products. Unfortunately, many companies are shying away from proceeding with their ideas because of the lack of understanding available FDA guidance.
  • In order to be well positioned for the future of AM, companies need to be fully aware of FDA regulations to better navigate the system. This presentation will provide guidance for manufacturers as they seek to develop products in the AM realm.
  • Through review of both relevant, real-life examples and hypothetical ones, the paper will help to define each FDA regulatory class of medical products.