Combination Products: BIO Comments on FDA Draft Guidance Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development”

Re: Docket No. FDA-2015-D-4848: Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development
Dear Sir/Madam:
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance entitled “Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development” (Draft Guidance).
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.
General Comments
BIO is appreciative of FDA’s efforts to provide greater clarity regarding human factors (HF) issues in the context of combination products that are comprised of a drug or biological product and a device, and “to promote the development and timely review of safe and effective combination products.”
Combination products are comprised of any combination of a drug, device or biologic product (e.g., drug-device, biologic-device, drug-biologic, or drug-device-biologic). Each constituent part of a combination product retains its original regulatory status and, therefore, the combination product is subject to the unique regulatory requirements applicable to each of its constituent parts.
Advances in personalized medicine and new drug delivery technologies have led to an ever-increasing number of combination products being co-developed to meet unmet needs. However, the FDA review structure on which Sponsors rely is one that was established at a time when products were being developed individually, which had led to redundancies and inconsistencies in the review of 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.
We greatly appreciate recent steps taken by the Agency to provide greater efficiency, consistency and predictability in the review of combination products.3 BIO believes that this Draft Guidance will provide additional clarity to sponsors related to HF studies in the development of combination products.
We offer specific comments on the Draft Guidance below, and in the accompanying chart, around several main themes: the need to ensure consistency with existing guidance and regulations regarding medical devices; clarification that HF studies are not clinical studies; and concerns with potentially shifting accountability for design control, risk assessment and change control from the applicant to the FDA.