FDA Touts 'Tremendous Progress' On Overhaul Of Combination Products Review Program

By Jof Enriquez,
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FDA officials report that, in the past year, the agency has made significant strides in implementing measures to make combination products reviews more efficient.

Feedback from focus groups, noting how industry has had to follow disparate requirements from different product centers, was consolidated by FDA in a report released a year ago. The report identified areas for improvement and recommendations to streamline regulation of combination products, which comprise any combination of a medical device and/or a drug, and/or a biologic.

FDA says the past year has seen "tremendous progress toward the goal of modernizing the combination products review program by improving coordination, ensuring consistency, enhancing clarity, and providing transparency within the Agency as well as with all stakeholders," wrote Nina L. Hunter, Ph.D., FDA’s Associate Director for Science Policy in the Office of Medical Products and Tobacco, and Robert M. Califf, M.D., FDA's Commissioner, in FDA Voice.

As much as 30 percent of all new healthcare products currently under development are combination products, and Califf reaffirmed previously the agency's commitment to follow through on steps to improve the conduct of combination product reviews.

Achievements in the past year included the issuance of more guidance on human factors, according to FDA. Specifically, these were draft guidances on human factors studies and clinical study considerations in combination product design and development, as well as final guidance on applying human factors and usability engineering to medical devices.

FDA plans to release draft guidance on its new process called Pre-Request for Designation (Pre-RFD), a quick and less formal method to seek FDA feedback during a combination's product's early stage of development, when the sponsor is contemplating a specific configuration of the product. FDA also wants to soon finalize draft guidance it released in January 2015, clarifying current good manufacturing practice (cGMP) requirements for combination products.

An updated guidance on medical product classification also is in the works.

Staff for three product centers: the Center for Devices and Radiological Health (CDRH) for medical devices, the Center for Biologics Evaluation and Research (CBER) for biologics, and the Center for Drug Evaluation and Research (CDER) for drugs, now have access to databases within 48 hours, instead of several weeks it took previously, according to Hunter and Califf.

FDA also wanted to facilitate data-sharing between centers, and in August started the pilot phase of its new intercenter consult request (ICCR) process, designed to streamline submissions and reviews of combination products.

Since the start of the pilot, FDA staff have "leveraged lean tools and concepts" and have begun "to clarify roles, establish subject matter experts & identify key points of contact for various disciplines" across centers, and soon will include contacts in Office of Combination Products, according to the officials.

The ICCR pilot is scheduled to end in mid-2017, at which time all staff across FDA's three centers will have trained on the same process, and going forward, will use the same form for monitoring submissions and consult requests, and peruse improved standard operating procedures and policies (SOPPs) and Staff Manual Guides on conducting reviews.

Overseeing the new ICCR process is the Combination Products Policy Council, a senior-level, agency-wide forum for discussing, resolving, and implementing product and policy issues governing combination products. Created by FDA in April 2016, the council will have decisional authority on issues relating to combination products, cross-labeled products, and medical product classification.