FDA NEWS: Naloxone App Competition, CDRH Priorities, NEST Report, ClinTrials.gov Requirements – Drug and Device Digest

FDA BRIEF: Week of September 19, 2016


Image result for 2016 Naloxone App Competition,

  • Public contest on developing innovative technologies to combat opioid overdose epidemic
    1. For: Computer programmers, public health advocates, clinical researchers, entrepreneurs, innovators from all disciplines
    2. Create: App to connect opioid users experiencing overdose with nearby naloxone (antidote) carriers
  • Goal to develop a low-cost, scalable, crowd-sourced App to increase accessibility
  • Registration Deadline : Oct. 7, 2016
  • Code-a-thon: Oct. 19-20, 2016, @ FDA campus
    1. Code: Open-source, publicly accessible; collaboration
  • Submission Deadline: Nov. 7, 2016. Submit video of functional prototype along with concept summary
  • Judging: FDA, NIDA, and SAMHSA
  • Award:  $40,000 + application for NIDA SBIR grant



  • Leverage “Big Data” for regulatory decision-making
  • Modernize biocompatibility and biological risk evaluation of device materials
  • Leverage real-world evidence in regulatory decision-making
  • Advance methods for predicting/monitoring medical device clinical performance
  • Improve and streamline clinical trial design
  • Develop computational modeling technologies  for regulatory decision-making
  • Enhance performance of Digital Health and strengthen medical device cybersecurity
  • Reduce healthcare associated infections by better understanding antimicrobials, sterilization, reprocessing of medical devices
  • Collect and use patient input in regulatory decision-making
  • Leverage precision medicine and biomarkers for predicting medical device performance, disease diagnosis and progression


National Evaluation System for health Technology (NEST) Report

Image result for A NEST Planning Board Report



  • Collaborative system leverages real-world evidence from  different sources (see above) to better understand how medical devices perform
  • Contribute to regulatory decisions, promote device innovation, provide timely and meaningful information directly to patients and health care providers


  • Published by  Duke-Margolis Center for Health Policy through cooperative agreement with FDA
  • Goals for Phase 1
    1. Balancing of pre- and postmarket device evidence development
    2. Active surveillance system
  • Goals for Phase 2
    1. Class 2 devices: Enhanced data collection and integrating health IT systems
    2. Patient-mediated data sharing
    3. Measuring device value



Image result for clintrial gov

Final rule on requirements for registering certain clinical trials and summary results  to ClinicalTrials.gov.

Legal requirements for submitting registration and results information for clinical trials involving FDA -regulated drug, biological and device products.

  • Access is good for patients, the public and science
  • Maximize value of clinical trials
  • Honor commitments to trial participants

Key elements:

  • Checklist for trial eligibility and responsibility
  • Expanded scope for summary results information
  • Additional registration and summary results information data –  race, ethnicity of trial participants, if collected, and the protocol
  • Additional types of adverse event information
  • List of potential legal consequences for non-compliance.


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