Requirement: Report the Timeliness in Days of the Assignment of Combination Products
FDA is to assign premarket review responsibility for combination products based on the product's PMOA. By submitting an RFD, a company may obtain a formal FDA determination of a combination product’s PMOA and assignment of the lead Center for the product’s premarket review and regulation. OCP must 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. As part of OCP’s review of an RFD submission, a product may be determined to be a non-combination product and classified as either a biologic, device, or drug.
OCP must also make classification determinations for non-combination RFD submissions. As with combination products jurisdictional determinations, non-combination product classification determinations must be made within 60 days of the filing of the RFD.
|Requirement Type||Requirement Time Frame|
|Request for Designation||60 calendar days|
Combination Product Assignment Requests
|Primary Center||Number of Product Assignments*|
|Combination Products||Non-Combination Products|
* Workload also included 52 RFD submissions that were reviewed by OCP and were either found to have insufficient information for filing or were withdrawn by sponsor after filing.
Ten requests for assignment of a combination product were carried over from FY 2007 (pending and not overdue as of October 1, 2007). An additional 34 assignment requests for combination products were filed during FY 2008. Of the 44 potential assignment requests in FY 2008, 22 were identified as combination products with 2 issued to CBER, 14 to CDER, and 6 to CDRH (see table to the right). Seventeen were identified as non-combination products with 6 issued to CBER, 8 to CDER, and 3 to CDRH. Five were carried over to FY 2009 (pending and not overdue assignment as of October 1, 2008).
In FY 2008, 39 total combination and non-combination product assignments were issued, all within the 60-day time frame (see table below). Over half (22 of 39) of product assignment requests were determined to be combination products. The combination product assignments had a median product assignment time of 59 days. Of the 22 combination product assignments issued, 19 combination products were determined to be drug-device combinations, 2 were device-biologic combinations, and 1 was a drug-biologic combination. The remaining (17 of 39) product assignment requests were determined to be non-combination product assignments with a median product assignment time of 58 days. Of the 17 non-combination product assignments issued, 8 were determined to be drugs, 3 were devices, and 6 were biologics/tissues.
Combination Product Requests for Assignment
|Determination||Product Assignments Issued||Product Assignments (Number) Within 60 days||Product Assignments (Percent) Within 60 days||Median Product Assignment Time (Days)||Range of Product Assignment Time (Days)|
|Combination Products*||22||22||100%||59||36 to 60|
|Non-Combination Products†||17||17||100%||58||28 to 60|
* Includes six RFDs that were pending at the beginning of FY 2008. Does not include one request for reconsideration for a combination product that was issued within the 15-day time frame provided by 21 CFR 3.8.
† Includes four RFDs that were pending at the beginning of FY 2008. Does not include three requests for reconsideration for a combination product that was issued with the 15-day time frame provided by 21 CFR 3.8.
More detailed FY 2008 RFD performance information is available at the OCP Web site: Request for Designation - Review Performance.
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