It’s been a busy week for the US Food and Drug Administration’s CDRH. In the space of a couple of days, the Center has published one final and two draft guidances related to Human Factors.
Just over a month into 2016 and the Center has already achieved 3 of its stated priorities for the year, with the release of these documents;
- Applying Human Factors and Usability Engineering to Medical Devices (Final Guidance),
- List of Highest Priority Devices for Human Factors Review (Draft Guidance),
- Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (Draft Guidance).
We’re hard at work in the office analysing the content of these documents, so we can give you a summary of the changes and requirements for your teams developing medical devices or combination products. We’ll be publishing a summary of the key pieces of information next week.
You may want to know how these guidances impact your planned or ongoing development activities. Send me an email to schedule a time to talk further.