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Performance Report
To Congress

for the

Office of Combination Products

as required by the

Medical Device User Fee and
Modernization Act of 2002

Commissioner’s Report

I am pleased to submit the Food and Drug Administration’s Fiscal Year (FY) 2006 Annual Report to Congress for the Office of Combination Products (OCP). This report includes the third full year of data since OCP was established as mandated by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), enacted on October 26, 2002.

Combination products are therapeutic and diagnostic products that combine elements of drugs, devices, and/or biological products. The Food and Drug Administration (FDA) is receiving significantly more combination products for review as technological advances continue to merge product types and blur the historical lines of separation between FDA’s medical product centers. Because combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they also raise challenging regulatory, policy, and review management issues. The differences in regulatory pathways for each component can impact the regulatory processes of all aspects of the product life cycle, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.

OCP has made significant progress in enhancing the transparency and predictability of the combination product lead Center assignment and review process. OCP has facilitated interactions between industry and FDA to clearly delineate regulatory paths, and implemented processes to ensure the timely and effective review, and consistent and appropriate postmarket regulation of combination products. One large industry trade association wrote us following a recent survey of its members to congratulate OCP on the progress made. The letter stated that “OCP has done an excellent job in meeting the goals outlined in MDUFMA in spirit and in practice.”

Combination products will continue to become more complicated as new technologies emerge and existing technologies mature. OCP, therefore, will continue to focus on the most important issues relating to combination products and actively assist industry and FDA reviewers in understanding this complex regulatory area.

FDA looks forward to continued success in meeting the unique challenges in the review and regulation of combination products.

                                                                         Andrew C. von Eschenbach, M.D.
                                                                         Acting Commissioner of Food and Drugs

Executive Summary

FDA established OCP on December 24, 2002, in response to MDUFMA. The mission of OCP is to ensure the prompt assignment of combination products (drug-device, biologic-device, drug-biologic, or drug-device-biologic products) to FDA Centers, the timely and effective premarket review of such combination products, and consistent and appropriate postmarket regulation of these products.

This document presents OCP’s annual report to Congress. OCP activities for FY 2006 highlighted in this report include the following:

• Prompt Assignment of Combination Products. OCP published a number of documents relating to the assignment of combination products in FY 2006. OCP published two Federal Register notices, one describing FDA’s preliminary review of agreements, guidance documents, and practices specific to the assignment of combination products. The other Federal Register notice announced that FDA was transferring responsibility of catheter lock-flush solution combination products from Center for Drug Evaluation and Research (CDER) to Center for Devices and Radiological Health (CDRH). OCP published a guidance document clarifying what is meant by the minimal manipulation of structural tissue. Several jurisdictional updates were published, including those for breath test combination products, and approximately 50 additional capsular descriptions of selected jurisdictional decisions were published. Additionally, OCP continued to provide prompt Request for Designations (RFD) decisions. OCP issued 26 combination product RFD assignments in the last fiscal year. One hundred percent of these assignments met the 60-day decision time requirement.
  
  
• Timely and Effective Premarket Review. In FY 2006, OCP continued to make significant contributions to the premaket review of combination products by directly facilitating complex review challenges. OCP also continued to provide help and support to internal and external stakeholders by serving as an informal resource for combination product regulatory and process issues. OCP published a guidance document outlining early development considerations for innovative combination products. Other OCP activities relating to premarket review include the organizing of a number of working groups to address specific regulatory issues pertaining to combination products. Specific issues addressed in FY 2006 include autoinjectors and new products intended to be used with another sponsor’s already approved product.
  
  
• Combination Product Review. FDA received 231 original applications for combination products in FY 2006. This amount represents a decrease of 15 percent from the 273 original applications for combination products in FY 2005. However, the number of intercenter consulting reviews increased to 335 for FY 2006 from 275 in FY 2005. This amount represents a 22 percent increase in intercenter consults. Recent examples of approved combination products can be found at http://www.fda.gov/oc/combination/approvals.html.
  
  
• Consistent and Appropriate Postmarket Regulation. In FY 2006, OCP announced its intention to promulgate two regulations to help ensure the consistent and appropriate postmarket regulation of combination products. These proposed rules would clarify current good manufacturing processes and postmarket safety reporting requirements. Additionally, OCP chaired and convened a working group considering postmarketing changes to combination products.
  
  
• Additional Activities and Impacts. OCP continued to conduct internal and external outreach activities through a variety of educational and informational presentations for both FDA staff and stakeholders. These activities were intended to foster greater efficiency of the combination product development and review process by enhancing understanding of the complex regulatory issues encompassing the review of combination products.

Throughout FY 2006, OCP endeavored to ensure the prompt assignment of combination products to Centers, the timely and effective premarket review of such products, and the consistent and appropriate postmarket regulation of these products. These activities help provide patient access to innovative technologies and address unmet medical needs through the timely delivery of safe and effective combination products to the public.

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