FDA News: Organs-on-Chips, Autism Therapy, America’s got Regulatory Talent, Class I Exempt Device Listing – Drug and Device Digest

FDA BRIEF: Week of April 10, 2017

‘Organs-on-Chips’ Technology: FDA Testing Groundbreaking Science

By: Suzanne Fitzpatrick, Ph.D., Senior Advisor for Toxicology, CFSAN

Emulate Chip

Creating human organ systems in miniature on micro-engineered chips

  • Flexible polymer organ-chips contain tiny channels lined with living human cells and are capable of reproducing blood and air flow just as in the human body
  • First developed to evaluate the effectiveness of drugs
  • Potentially useful technology to ensure food

Public-Private Collaboration

  • Universities- Harvard, MIT
  • Emulate founded by researchers at the Wyss Institute for Biologically Inspired Engineering, Harvard University


 Autism: Beware of Potentially Dangerous Therapies and Products

There is no cure for autism

  • Products or treatments claiming to “cure” autism do not work as claimed
  • Same true of products claiming to “treat” autism or autism-related symptoms
  • Some may carry significant health risks
  • Examples: Chelation Therapies,  Hyperbaric Oxygen Therapy, Detoxifying Clay Baths, various products, including raw camel milk and essential oils

FDA guidance on products with improper claims about intended use

  • Be suspicious of products that claim to treat a wide range of diseases
  • Personal testimonials are no substitute for scientific evidence
  • Few diseases or conditions can be treated quickly, so be suspicious of any therapy claimed as a “quick fix.”
  • So-called “miracle cures,” which claim scientific breakthroughs or contain secret ingredients, may be a hoax


 America’s Got Talent – Regulatory Science Style

By: Stephen Ostroff, M.D., Acting FDA Commissioner

America's Got Regulatory Science EventStudents compete by presenting their proposed solutions to a current challenge in regulatory science

  • University of Maryland’s Center of Excellence in Regulatory Science and Innovation (CERSI)
  • University of Rochester’s Clinical and Translational Science Institute (CTSI)

The students identify the needs by consulting eight priority areas identified in FDA’s Strategic Plan for Regulatory Science

  • Judged quality and novelty
  • Proposed solution’s potential significance and feasibility
  • Winning teams come to FDA to formally present ideas and have discussions with Agency scientists


List of Class I Exempt Devices

List of class I devices that are now exempt from premarket notification requirements

  • In accordance with procedures established by the 21st Century Cures Act
  • Will decrease regulatory burdens on the medical device industry
  • Will eliminate private costs and expenditures required to comply with certain Federal regulation



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