FDA Brief: Week of Mar 21, 2016


FDA Voice


Addressing Issues Relating to Combination Products: Human Factors (HF)


Jill Hartzler Warner, J.D., Associate Commissioner for Special Medical Programs

Thinh Nguyen, Director, Office of Combination Products

  • Combination products combine a drug, device, and/or biological product

May be physically or chemically combined; co-packaged; or separately distributed with specific labeling for combined use

  • If medical device constituent – HF engineering important for safe and effective use

Study how people interact with technology, how design of user interfaces affects  quality, experience, and outcomes of interaction

  • Feb 2016, draft guidance on HF studies (posted in BLOG )
    • timing and sequencing
    • new studies to qualify product changes
    • simulated vs actual use
    • FDA requirements
  • FDA seeking comments on draft







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