Important FDA Guideline on Combination Products published

Recommendation

Thursday, 16 July 2020 14.00 - 15.30 h

Webinar: Chances through the postponement of the Medical Device Regulation – one year of additional time

In February 2016, the FDA published the Guideline "Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development". The document addresses the "Human Factors Studies" during the development of combination products.

In the USA, combination products are defined in 21 CFR Part 4. Basically, human factors studies are performed to evaluate how patients can handle a product. Regarding this, the FDA often receives requests about how to apply the HF concepts to the development of combination products.

The new Guideline presents the principal concepts of "Human Factors Studies".

A prefilled syringe has been taken as a concrete example. In the end, 2 appendices in form of a table provide examples of critical aspects related to the use of combination products and their typical failures and difficulties:

• Table 1 addresses injection combination products 
• Table 2 addresses inhalation combination products

Please see the complete FDA Guidance "Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development" for the details.

In addition, the following two Guidances of the FDA regarding this topic have also been published:

• Applying Human Factors and Usability Engineering to Medical Devices and
• List of Highest Priority Devices for Human Factors Review.