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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 - 2011

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TimeTargetPercentage of RFD Decisions
Oct 2010100100
Nov 2010100100
Dec 2010100100
Jan 2011100100
Feb 2011100100
Mar 2011100100
Apr 2011100100
May 2011100100
Jun 2011100100
Jul 2011100100
Aug 2011100100
Sep 2011100100

FY 2011 Overall: 100%

Total number of RFD decisions issued within the month

Fiscal Year - 2011
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TimeTargetNumber of Decisions
Oct 2010N/A3
Nov 2010N/A4
Dec 2010N/A2
Jan 2011N/A3
Feb 2011N/A1
Mar 2011N/A4
Apr 2011N/A4
May 2011N/A2
Jun 2011N/A3
Jul 2011N/A5
Aug 2011N/A5
Sep 2011N/A3

FY 2011 Total: 39


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.