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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 June 30, 2014.

Fiscal Year - 2010

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TimeTarget (Percentage)Percentage of RFD Decisions
Oct 2009100100
Nov 2009100100
Dec 2009100100
Jan 2010100100
Feb 2010100100
Mar 2010100100
Apr 2010100100
May 2010100100
Jun 2010100-
Jul 2010100100
Aug 2010100100
Sep 2010100100

FY 2010 Overall: 100%

Total number of RFD decisions issued within the month

Fiscal Year - 2010
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TimeTargetNumber of Decisions
Oct 2009N/A3
Nov 2009N/A4
Dec 2009N/A7
Jan 2010N/A5
Feb 2010N/A3
Mar 2010N/A3
Apr 2010N/A4
May 2010N/A4
Jun 2010N/A0
Jul 2010N/A3
Aug 2010N/A3
Sep 2010N/A5

FY 2010 Total: 44

Glossary

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.