September 2018 – Drug and Device Digest

News and Views: Digital Health Innovation, Facilitating Third Party Review, Drug Supply Chain Security, Flu Vaccinations, Rare Diseases Grants, Collaborative Communities Toolkit


FDA Budget Matters: Advancing Innovation in Digital Health

Digital health tools have vast potential to diagnose and treat disease, enhance delivery of health care for the individual

  • modern, flexible, risk-based approaches to regulation
  • launched our Digital Health Innovation Action Plan
  • committed to launching the digital health software precertification pilot program

Sought additional resources as part of the FDA’s FY2019 Budget

  • Create Center of Excellence for Digital Health (CoE) to advance pre-certification model
  • Building a new capacity to evaluate third-party certifiers of digital technologies
  • Create cybersecurity unit to complement the advances in software-based devices,


Capture.JPGEliminating Routine FDA Re-Review of Third Party 510(k) Reviews

Updating 510(k) Third Party (3P) Review Program to avoid routine re-review of 510(k) submissions already reviewed by a 3P Review Organization (3PRO)

  • Ensuring eligible device types are appropriate
  • Giving 3PRO reviewers tools needed to succeed
  • Providing way to demonstrate successful application of FDA’s 510(k) criteria
  • Implementing comprehensive framework for processing of submission packages
  • Using program measures to monitor 3P Review Program



FDA advances policies related to bolstering security of drug products in the U.S. supply chain

Guidances  to ensure that prescription drug products are identified and traced properly as they move through the supply chain in compliance with federal law


Preparations for the upcoming flu season and vaccinations

FDA has a key role in selecting strains to be included in seasonal flu vaccines

  • Designed to target three or four of the most likely viruses:  two influenza A types (H1N1 and H3N2) and one (trivalent formulation) or two (quadrivalent formulation) types of influenza B
  • FDA, World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC) review data collected on globally circulating strains
  • Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in March 2018 to select strains for upcoming season
  • Addressed last year’s challenges with selection of  less protective strains
  • Ensures released lots meet appropriate standards including testing for sterility.

Seasonal flu vaccine one of the most effective and safest ways to protect



FDA awards 12 grants to advance rare diseases medical products 

FDA awarded grants through Orphan Products Clinical Trials Grants Program for clinical studies for treatment of rare diseases

  • Reviewed and evaluated for scientific and technical merit by more than 100 rare disease experts (academia, NIH, FDA)
  • Created in 1983, has provided > $400 million to fund > 600 new clinical studies

Grant recipients 

  • Alkeus Pharmaceuticals, Inc., Arizona State University-Tempe Campus, Cedars-Sinai Medical Center, Columbia University of New York,  Emory University,  Fibrocell Technologies, Inc.,  Johns Hopkins University,  Oncolmmune, Inc.,  Patagonia Pharmaceuticals, LLC,  The General Hospital Corporation, University of Minnesota, University of North Carolina at Chapel Hill


CaptureCollaborative Communities Toolkit 

Collaborative community is private- and public-sector forum (including FDA)  to work together on medical device challenges

  • Challenges are ill-defined or there is no consensus on the definition
  • Challenges and outcomes are complex
  • Partners are interrelated
  • Incremental or unilateral efforts to address the challenge have been ineffective
  • Partners seek to optimize efforts, including preventing duplication of efforts
  • Better outcomes could be achieved with integrating different perspectives, experiences, resources, and expertise


  • Collection of materials designed to help a community become established, to encourage effective collaboration, and foster rich communities to take on healthcare challenges


Image credit: FDA



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