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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 - 2014

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TimeTargetPercentage of RFD Decisions
Oct 201395100
Nov 201395100
Dec 201395100
Jan 201495100
Feb 201495100
Mar 201495100
Apr 201495100
May 201495100
Jun 201495100
Jul 201495100
Aug 201495100
Sep 201495100

FY 2014 Overall: 100%

Total number of RFD decisions issued within the month

Fiscal Year - 2014
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TimeTargetNumber of Decisions
Oct 2013N/A3
Nov 2013N/A1
Dec 2013N/A2
Jan 2014N/A2
Feb 2014N/A0
Mar 2014N/A0
Apr 2014N/A1
May 2014N/A3
Jun 2014N/A2
Jul 2014N/A2
Aug 2014N/A1
Sep 2014N/A1

FY 2014 Total: 18


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.