FDA Voice: Human Factors and Combination Products
FDA Brief: Week of Mar 21, 2016
Addressing Issues Relating to Combination Products: Human Factors (HF)
By:
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- Feb 2016, draft guidance on HF studies (posted in BLOG )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