MedTech Dive September 13, 2023
AdvaMed called overlapping human factor requirements of the draft guidance “overly burdensome.”
Dive Brief:
- The Food and Drug Administration has finalized its guidance on the application of human factors engineering principles to combination products.
- Officials released a draft version of the guidance for consultation in 2016 but received pushback from AdvaMed. The medtech trade group called the overlapping human factor requirements of device and combination product guidance documents “overly burdensome.”
- More than seven years later, the FDA has finalized the combination product guidance. The final text differs from the draft version, with the FDA switching to a question-and-answer format and rewriting almost all of the text.
Dive Insight:
Concerns about overlapping requirements between a 2011 FDA document about...
Today's Sponsors
Today's Sponsor