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

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

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

FDA joined MDSAP RAC  to participate in pilot

MDSAP

• 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 )

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MDUFA Performance Report

Guidance 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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