FDA established OCP on December 24, 2002, as required by MDUFMA I. 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 and covers FY 2008, the period from October 1, 2007 through September 30, 2008. OCP activities for FY 2008 highlighted in this report include the following:
- Prompt Assignment of Combination Products. In FY 2008, OCP continued to clarify the jurisdictional assignment of combination products and to provide prompt Request for Designation (RFD) decisions.1 OCP published three RFD letters for approved or cleared products and issued 22 combination product RFD assignments with 100 percent of these assignments meeting the 60-day statutory decision time requirement. OCP also continued to provide informal jurisdictional assistance for approximately 190 separate issues.
- Timely and Effective Premarket Review. In FY 2008, OCP published draft guidance for medical imaging products as mandated by MDUFA II. The guidance clarifies the approaches for product development and submission of applications by device and drug developers and is available at: Combination Products Guidance Documents. OCP also continued to make significant contributions to the premarket review of combination products by directly facilitating complex review challenges. OCP provided help and support to internal and external stakeholders by serving as an informal resource for combination product regulatory and process issues. Other OCP activities relating to premarket review included organizing a number of working groups to address specific regulatory issues pertaining to combination products. Several working groups were chaired by OCP to help delineate the regulatory pathway for injectors and for pharmacogenomic drug-diagnostic devices. Additionally, OCP participated in a number of FDA working groups examining issues related to nanotechnology, artificial pancreas, biologics and tissues, premarket issues, product labeling, and wound care products. OCP was also an active participant in FDA-wide data standard and bioinformatic initiatives to enhance premarket and postmarket activities, such as, electronic adverse event reporting, application submission management, product quality issues, and drug eluting stents.
- Combination Product Review. FDA received 330 original applications for combination products in FY 2008. This amount represents an increase from 329 original applications for combination products received in FY 2007. The number of intercenter consulting reviews slightly decreased to 371 for FY 2008 from 390 in FY 2007. This represents a 5 percent decrease in intercenter consults. Examples of approved combination products can be found at the OCP Web site.
- Consistent and Appropriate Postmarket Regulation. In FY 2006, OCP announced its intention to prepare two regulations to help ensure the consistent and appropriate postmarket regulation of combination products. Accordingly in FY 2008, OCP continued progress toward publication of these proposed rules. These proposed rules would clarify current good manufacturing practices (cGMPs) and postmarket safety reporting requirements. In FY 2008, OCP convened and chaired working groups for combination product registration and listing and on cGMPs for combination products. Other activities undertaken by OCP include a variety of postmarketing and compliance-related matters for 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. OCP also conducted activities that advance the development and review of innovative products associated with personalized medicine and FDA’s Critical Path Initiative. Other activities included participation in FDA bioinformatics initiatives, participation in the development of a final rule on drug registration and listing, interactions with international regulatory agencies, and the redesign of the FDA Internet and Intranet sites.
Throughout FY 2008, OCP strived to ensure the prompt assignment of medical products to Centers, the timely and effective premarket review, and the consistent and appropriate postmarket regulation of combination 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.
1An RFD is submitted to obtain a formal product classification and jurisdiction determination for a product. OCP issues RFD decisions for both combination and non-combination products.
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