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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 March 31, 2020.

Fiscal Year - 2020

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TimeTargetPercentage of RFD Decisions
Oct 2019N/A100
Nov 2019N/A100
Dec 2019N/A100
Jan 2020N/A75
Feb 2020N/A100
Mar 2020N/A100
Apr 2020N/ATBD
May 2020N/ATBD
Jun 2020N/ATBD
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD Average: 96%

Total number of informal decisions issued within the month

Fiscal Year - 2020
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TimeTargetNumber of Decisions
Oct 2019N/A5
Nov 2019N/A5
Dec 2019N/A4
Jan 2020N/A4
Feb 2020N/A3
Mar 2020N/A4
Apr 2020N/ATBD
May 2020N/ATBD
Jun 2020N/ATBD
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 25

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.

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