OCP promptly assigns a Center with primary jurisdiction for a combination product and reviews and updates agreements, guidance documents, and practices specific to the assignment of combination products, among other activities. OCP is required to assign premarket review responsibility for combination products based on the product's primary mode of action (PMOA).3 By submitting an RFD, a company may obtain a formal FDA determination of a combination product’s PMOA and of assignment of the lead Center for the product’s premarket review and regulation.4 FDA will make its jurisdictional determination within 60 days of filing the RFD, or the sponsor’s recommendation of the Center with primary jurisdiction will become the assigned Center.5 In addition, companies and Centers often informally request assistance from OCP in working out jurisdictional issues not raised in an RFD submission.
OCP FY 2008 activities and impacts related to the assignment of combination products are as follows:
- Issued all assignments, due as of September 30, 2008, within the 60 days provided by 21 CFR 3.8. RFD performance data for the assignment of combination and non-combination products in FY 2008 are found in the next section of this report.
- Responded to 190 informal internal and external stakeholder inquiries by providing advice, guidance, and clarification on a variety of issues related to the assignment of combination products. In addition to OCP’s review and response to RFDs submitted by industry, OCP responded to 190 stakeholder inquiries related to product classification/jurisdiction assignment, primarily by e-mail and telephone. OCP received 40 more informal requests for classification and jurisdictional assignment in FY 2008 than during FY 2007.
- Published 3 RFD decision letters for products that have been approved or cleared. FDA can only publish RFD decision letters for approved or cleared products. The RFD decision letters, posted on the OCP Web site, are redacted to remove trade secret and confidential commercial information. Publishing these letters, which generally include FDA’s reasoning in making the jurisdictional determination, is intended to provide additional transparency for the jurisdictional decision making process. Over 60 letters are currently posted, and OCP plans to post additional letters on a regular basis. The letters are available on the OCP Web site.
- Continued monthly product jurisdiction meetings for the exchange of information between OCP jurisdictional and assignment specialists, and CBER, CDER, and CDRH product jurisdiction officers. This venue provides for an open discussion of, and progress report on, RFDs and other jurisdictional decisions pending or made in the Centers, and enhances the timeliness, consistency, and clarity of jurisdictional decisions across FDA.
3 This is in accordance with section 503(g)(1) of the Act (21 U.S.C. 353(g)(1).
4 The RFD process, including the information required in a RFD submission, is outlined in 21 CFR Part 3.
5 This is by operation of section 563 of the Act (21 U.S.C. 360bbb-2).
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