A structured checklist to guide Human Factors Engineering (HFE) considerations for medical device submissions.
| ID | Title | Source | Description |
|---|---|---|---|
| 12 | Applying Human Factors and Usability Engineering to Medical Devices | FDA Guidelines | Final guidance document (2016) emphasizing the importance of HFE in medical device safety and regulatory submissions. |
| 13 | Content of Human Factors Information in Medical Device Marketing Submissions | FDA Guidance Draft | Draft guidance outlining required HFE data for 510(k) submissions. |
| 14 | Human Factors: An Investment that Pays for Itself | MPO Article | Discusses the financial benefits and strategic advantages of robust human factors evaluations in medical device development. |
| 15 | Cost Implications of Medical Device Recalls | PubMed Analysis | Analyzes the financial impact of product recalls attributed to design issues related to human factors. |
| 16 | FDA and IEC 62366: usability Standards for Medical Devices | AAMI Resources | Covers international standards and regulatory requirements for human factors engineering in medical device development. |