On January 17, 2016, the FDA published the draft guidance for industry, “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.” The draft guidance is intended to assist potential applicants who plan to submit, and seek approval of, a generic combination product that includes both a drug constituent part and a device constituent part. The recommendations included in the guidance generally focus on the analysis of the proposed user interface of the generic drug-device combination product (“generic combination product”) when compared to the user interface for its reference listed drug (RLD).
The draft guidance outlines:
- the types of threshold analyses applicants should utilize when developing the user interface of a proposed generic combination product
- assessments to determine whether additional information and/or data, such as data from comparative use human factors studies, may be warranted to assess the acceptability of differences identified in the user interface of the proposed generic product compared to its RLD
- considerations on the design and conduct of comparative use human factors studies that may help potential applicants determine whether identified differences in the user interface of a proposed generic combination product compared to its RLD would preclude approval of the proposed generic combination product in an ANDA
While the FDA does not expect that the proposed generic combination product and its RLD will be identical in all respects, potential applicants should carefully consider the design of the user interface of a proposed generic combination product throughout their development process and seek to minimize differences when compared to the user interface for its RLD. The FDA strongly recommends that potential applicants contact the FDA through a controlled correspondence and/or pre-ANDA meeting request (via email at firstname.lastname@example.org) to discuss the results of the threshold analyses prior to conducting comparative use human factors studies.
The recommendations described in this guidance are intended to complement other existing Agency authorities and processes.
To comment on the draft guidance, please visit the public docket, FDA-2016-D-4412.
Direct link to the draft guidance: http://www.fda.gov/downloads/
Drugs/ GuidanceComplianceRegulatoryIn formation/Guidances/UCM536959. pdf