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Medical Device Regulation: How to Classify Your Device

Recording of a Learn and Connect event sponsored by Children's Hospital of Philadelphia Innovation Ecosystem

Published onAug 21, 2023
Medical Device Regulation: How to Classify Your Device
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The process of FDA classification and regulation can be time-consuming and confusing for inventors and researchers working to bring medical devices to market.

In this Learn & Connect event, Dr. Jason Van Batavia - a CHOP pediatric urologist, Academic Entrepreneurship chapter author, and co-creator of the UroGenie - reviews how to

  1. Determine what is considered a medical device and differentiate between medical device classifications, as defined by the FDA.

  2. Distinguish between FDA regulatory pathways for medical devices and discern which pathways to consider based on device classification​.

Presenter


Jason Van Batavia, MD, MSTR

  • Pediatric Urologist, Children’s Hospital of Philadelphia

  • Assistant Professor of Urology in Surgery, Perelman School of Medicine​

  • Co-Creator of the UroGenie​

Presentation


https://www.youtube.com/watch?v=iOvpmZhQeTA

Introduction to Medical Device Regulation

Related and Referenced Chapters


Batavia, J. V., & Goldenberg, S. (2019). FDA Device Regulation: 510(k), PMA. In Academic Entrepreneurship for Medical and Health Sciences. https://doi.org/10.21428/b2e239dc.40f6dbdc

Batavia, J. V., & Goldenberg, S. J. (2019). Strategic Planning and Costs of FDA Regulation. In Academic Entrepreneurship for Medical and Health Sciences. https://doi.org/10.21428/b2e239dc.9f7895e5

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