Providing More Guidance and Agency Experts Among FDA Combination Products Priorities

By MedTech Intelligence Staff
December 5, 2016


• Categories: 05-Quality/Regulatory, Combination Products, RC - Medtech Regulatory Resource Center

Last year FDA released its Combination Products Review, Intercenter Consult Process Study Report, an eight-page document that made recommendations around areas that the agency needs to address in modernizing the combination products review program.

“As technologies advance across multiple fields, the distinctions that previously allowed combination products to be neatly categorized by FDA’s medical product centers are blurring or even vanishing.” – Nina Hunter, Ph.D. and Robert Califf, M.D., FDA

Among key priorities from last year’s report were providing more guidance for product review, simplifying data access and sharing for internal agency staff, and improving internal standard operating procedures related to premarket reviews and compliance activities. Last week FDA outlined next steps to the commitments it made last year including:

• Finalize Guidance on Human Factors, CGMP, Post approval Modifications and Final Rule on Postmarket Safety Reporting
• Issue guidance on Pre-RFD progress for requesting early feedback on combination products
• All staff involved with combination products review to be trained on the same process and use some request form to monitor submissions and consult requests
• Provide key contacts in the Office of Combination Products and other agency centers for product review
• Draft and implement staff manual guides to improve other areas of agency review