Q&A Guidance Clarifies Human Factors Testing For Combination Products

A highly anticipated final guidance from the FDA on Human Factor Studies answers frequently asked questions about human factor studies when designing combination products. 

A woman opens an auto injector by taking off the blue cap.
• Source: Shutterstock

In the long-awaited final guidance, Application of Human Factors Engineering (HFE) Principles for Combination Products: Questions and Answers, the US Food and Drug Administration addresses frequently asked questions about human factor studies in combination product design and development.

The guidance, published 8 September, is written in an uncharacteristic question-and-answer format responding to 15 frequently asked questions about human factors engineering.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Guidance

Global Medtech Guidance Tracker: April 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.

‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.

Guidance Feedback Highlights Outstanding Questions In AI Development

 
• By 

Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.

More from Compliance

Global Medtech Guidance Tracker: April 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.

‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.