Change Combination Product Guidance: Stakeholders
AdvaMed says it would like to better understand the relationship between an FDA draft guidance on human factor studies and related clinical study considerations in combination product design and development and a recently issued guidance on applying human factors and usability engineering to medical devices. Commenting on the new draft, the association says that the two human factors guidance documents are redundant for combination products that are regulated as devices. “It is overly burdensome, for example, to require combination products to conduct two different risk analyses and submit two different sets of data to FDA,” it says…. “Closer alignment between this guidance and existing documents may help prevent an increase in time or duplication of efforts by both applicants and FDA, for example, by increasing the scope, formality, and time for investigational and marketing application reviews.” AdvaMed also submits comments on specific sections of the draft.
In its comments, BIO says that while advances in personalized medicine and new drug delivery techniques have led to an increasing number of combination products being co-developed to meet unmet needs, the FDA review structure on which sponsors rely is one that was established at a time when products were being developed individually, which has led to redundancies and inconsistencies in reviewing combination products. “Greater clarity and alignment of the regulatory requirements applicable to the constituent parts, and coordination between Centers during the review of a combination product is absolutely essential to timely and efficient review of these products,” the letter says. BIO provides specific comments on several themes: the need to ensure consistency with existing medical device guidance and regulations, clarification that human factor studies are not clinical studies, and concerns with potentially shifting accountability for design control, risk assessment, and change control from an applicant to FDA.
Regeneron Pharmaceuticals says it “applauds the agency’s efforts to consolidate a number of previous draft guidance documents by different Centers on human factor studies and combination product development…. In general, the scope of this guidance could be enhanced to include clarification on the content of labeling and the use of human factor studies to support injection time requirements for combination products.”
Finally, Pharmaceutical Research and Manufacturers of America says it recognizes FDA efforts to enhance the combination products review process, including its engagement in a lean process mapping initiative to inform the future state of combination products review, and the recent launch of a Combination Products Policy Council to address issues relating to combination products, cross-labeled products, and medical product classification. Its letter includes specific comments on several areas of interest to its members: the intersection of the draft guidance and related guidance documents and standards; whether human factor studies should be considered a type of clinical study; specific terminology, concepts, and definitions used in the draft; sponsor/FDA communications during combination product development and review; review of human factor studies and certain labeling in marketing applications; and review of human factors information in combination product investigational applications.