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U.S. Department of Health and Human Services

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Percentage of informal requests decisions issued within 60 days

Dictionary: The Office of Combination Products (OCP) is responsible for classifying products as either drugs, devices, biological products, or combination products and assigning the product to a Center for premarket review and regulation. A sponsor may submit a formal RFD for a legally binding determination, and/or a sponsor may obtain a legally non-binding determination, of a product’s classification and Center assignment by the submission of an informal inquiry to OCP. OCP’s informal assessment enables the Agency (similar to a formal RFD determination) to assign a particular product to the appropriate agency component for premarket review and regulation (CDER, CBER, or CDRH). These formal and informal is jurisdictional determinations also enables the Agency to regulate the product under the appropriate regulatory authorities (NDA, 510(k), PMA, or BLA).

Information is current as of September 30, 2019.

Fiscal Year - 2019

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TimeTargetPercentage of RFD Decisions
Oct 2018N/A100
Nov 2018N/A86
Dec 2018N/A100
Jan 2019N/A100
Feb 2019N/A100
Mar 2019N/A100
Apr 2019N/A100
May 2019N/A83
Jun 2019N/A100
Jul 2019N/A100
Aug 2019N/A100
Sep 2019N/A89

FY 2019 Total: 97%

Total number of informal decisions issued within the month

Fiscal Year - 2019
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TimeTargetNumber of Decisions
Oct 2018N/A5
Nov 2018N/A7
Dec 2018N/A9
Jan 2019N/A6
Feb 2019N/A6
Mar 2019N/A6
Apr 2019N/A6
May 2019N/A6
Jun 2019N/A8
Jul 2019N/A7
Aug 2019N/A9
Sep 2019N/A9

FY 2019 Total: 84

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.