FDLI Hosted a Virtual Conference on November 9-10, 2021 Digital Health Technology and Regulation in Covid-19 and above. One of the major events was the panel on “FDA Digital Health Excellence Center Working with FDA on Digital Health. On the panel were Bacchus Patel – Director of CDRH Digital Health Excellence Center, Zachari Henderson – Head of Level Health Law and Diane Johnson – Executive Director of Strategic Regulatory MD&D by Johnson & Johnson. Shelton Buettner, chief legal adviser to the Mediterranean, discussed the panel discussion.

Below are three key points from the panel discussion.

  1. Action intentionally. This is a key concept in the development of digital health products. The panelists discussed the need to create and develop products in the digital health space and to understand how the inclusion or modification of certain functions can affect the level of control. Bacchus Patel, director of the Center for Digital Health Excellence, emphasized the need to dismantle and analyze digital health software products, particularly in its dealings with the FDA, to assess and evaluate how the product could fall under FDA control.
  2. Early relationships. The moderators discussed how much information should be provided to the FDA in the initial stages of the relationship and what detail is important in the early stages. Bacchus Patel says producers need to be balanced, not overbearing. Ideally, the FDA would require companies to read the relevant FDA guidelines and come to the FDA with specific questions about how the guidelines apply.
  3. Development of guidelines. The FDA said. Announced its purpose Publish marketing input recommendations for AE / ML Device Transformation Plans Action for 2022 MAL Software Software. In addition, the FDA’s final report on Digital Health Software Preliminary Testing Program It is expected to be published soon, outlining the main points learned from the pilot. The examples in the FDA guide are very useful and the FDA continues to find ways to provide helpful examples that provide sufficient detail without having to apply to different stakeholders. The FDA recognizes the importance of examples in guide documents and states that the relationship and feedback with industry stakeholders is important to provide detailed and meaningful guidance and examples to the industry.

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