Pre-Market Human Factors Submissions and Summative Testing Protocols
Many products and devices going through the FDA pre-market approval process will require documentation of your human factors work. Both FDA/CDER and CDER have established guidelines on how to organize this information.
HCS has extensive experience in authoring the Human Factors report requested by FDA’s human factors groups. We can synthesize your current documentation and material into the report format outlined in the FDA 2011 human factors guidance, or we can critique and modify your report drafts to match the FDA’s expectations.
Testing protocols, especially the human factors summative validation test, are often requested by FDA prior to data collection. HCS can assist you in preparing protocols that include the needed information for reviewers and identify potential deficiencies in testing methodology that could result in costly requests for additional information by the agency.
Device and combination product manufacturers often are concerned that their human factors activities have not been systematically integrated with their overall product development process. Also, with the advent of the international usability standard for medical devices, IEC 62366, you need to align your human factors and usability activities in order to comply with this standard needed for certification and CE Mark.
HCS offers a variety of services in this area. These services include
- Audits of your current human factors activities vs. the FDA’s Design Controls phases, or vs. the Usability Engineering Process described in IEC 62366: 2015.
- Complete authorship of SOP work instructions of human factors within your Design Controls procedure documentation.
- Reviews of your IEC 62366 Usability Engineering File for completeness and alignment with this standard’s intent.