FDA News: Traumatic Brain Injury, MDSAP Pilot, MDUFA III Metrics – Drug and Device Digest

FDA BRIEF: Week of September 5, 2016

Traumatic Brain Injury (TBI): FDA Research and Actions

Causes of Traumatic Brain Injury - 4 Photos (350x350)

TBI and Unmet Need

  • Often caused by bump, blow, jolt, or explosive blast to the head, or a penetrating head injury that disrupts the brain’s normal function
  • ~ 2.5 million TBI emergency department visits /year; 30% all injury-related deaths
  • Hard to diagnose
  • Can cause short- or long-term complications
  • Need for sensitive and objective diagnostic methods

FDA Research

  • Diagnostic measures of mild TBI
  • Studying biomarkers e.g. brain imaging, biofluid, physical indicators such as eye tracking and electroencephalography

FDA Regulations

  • Cleared devices to help determine need for imaging following head injury
  • Recent approval of  ImPACT and ImPACT Pediatric (review) to assess cognitive function following a possible concussion.
  • NO cleared medical products intended to specifically diagnose or treat TBI.

FDA Collaboration

  • Working with research and clinical community to develop better-designed clinical studies
  • Hosted  public meeting in March 2016
  • Plans to provide recommendations to address challenges in biomarker development


Medical Device Single Audit Program’s Regulatory Authority Council (MDSAP – RAC)

Image result for MDSAP image

FDA joined MDSAP RAC  to participate in pilot


  • Envisioned by International Medical Device Regulators Forum (IMDRF)
  • In collaboration with Australia, Brazil, Canada, and Japan regulatory authorities
  • Enables medical device manufacturers to contract with an MDSAP-authorized Auditing Organization (AO) to conduct a single audit
  • Learning Modules posted (Link and Learn )


MDUFA Performance Report

mdufaGuidance Documents issued: 37

FY 2016 User Fee collections: $137,677,000 (authorized)

Metrics for:

  • PMA Originals and Panel Track Supplements
  • PMA 180 Day Supplements
  • PMA Real Time Supplements
  • Pre-Market Report Submissions
  • PMA Annual Metrics and Goals
  • 510(k) MDUFA III Performance
  • 510(k) Annual General Metrics
  • Annual Metrics for De Novo Requests
  • Pre-Submissions
  • CLIA Waiver Annual Metrics
  • Investigational Device Exemptions (IDEs)
  • Dual (510(k) and CLIA Waiver) Annual Metrics

Internal Training:

  • Premarket Reviewer Training
  • Leadership Training


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