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U.S. Department of Health and Human Services

About FDA

Percentage of RFD decisions issued in the month reviewed within 60 days

Dictionary: The Office of Combination Products (OCP) is responsible for classifying products as either drugs, devices, biologics, or combination products and to assign the product to a Center for regulation. By submitting a RFD, a company may obtain a formal FDA determination of the status of their product. OCP must respond to a RFD within 60 days, or the requestor's recommended classification stands. A proper determination by OCP will enable the Agency to assign a particular product to the appropriate agency component for premarket review and postmarket regulation (CDER, CBER, or CDRH), and also enable the Agency to regulate the product under the proper regulatory authorities (NDA, 510(k), PMA, or BLA).

Information is current as of December 31, 2014.

Fiscal Year - 2013

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TimeTargetPercentage of RFD Decisions
Oct 2012100100
Nov 2012100100
Dec 2012100100
Jan 2013100100
Feb 2013100100
Mar 2013100100
Apr 2013100100
May 2013100100
Jun 2013100100
Jul 2013100100
Aug 2013100100
Sep 2013100100

FY 2013 Overall: 100%

Total number of RFD decisions issued within the month

Fiscal Year - 2013
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TimeTargetNumber of Decisions
Oct 2012N/A1
Nov 2012N/A4
Dec 2012N/A2
Jan 2013N/A2
Feb 2013N/A1
Mar 2013N/A3
Apr 2013N/A1
May 2013N/A3
Jun 2013N/A1
Jul 2013N/A4
Aug 2013N/A6
Sep 2013N/A4

FY 2013 Total: 32


Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.