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U.S. Department of Health and Human Services

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Cumulative percent of device types/product codes evaluated

Data for this measure is reported on a calendar year basis.

Dictionary: CDRH 2014-2015 Strategic Priority: Strike the Right Balance Between Premarket and Postmarket Data Collection

Goal: Assure the appropriate balance between premarket and postmarket data requirements to facilitate and expedite the development and review of medical devices, in particular high-risk devices of public health importance

Striking the right balance between premarket and postmarket data collection reflects a total life cycle approach to understanding the benefit-risk profile of medical devices. If – when appropriate – some premarket data needs can be shifted to the post market setting, CDRH can directly impact patient access to high-quality, safe, and effective medical devices of public health importance. This program measure assesses the cumulative percentage of device types subject to a PMA that have been reviewed to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification. The December 31, 2014 target is 50%.

For more information about balancing the need for premarket and postmarket data collection, please see CDRH’s guidance at: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications

The final target date for this measure was 12/31/2015. Data for this measure will no longer be updated.

Information is current as of February 24, 2016

Fiscal Year - All

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Data for this measure is reported on a calendar year basis.

TimeTargetPercent
Mar 2014-0%
Jun 2014-2%
Sept 2014-19%
Dec 201450%69%
Mar 2015-75%
Jun 201575%85%
Sept 2015-90%
Dec 2015100%100%

Footnotes

  • The target for this measure is progressive and will be updated every 6 months. The target for this measure was 50% for December 31, 2014, 75% by June 2015, and will be increased to 100% by December 2015.

Cumulative number of device types/product codes evaluated in the quarter

Fiscal Year - All
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TimeTargetNumber
Mar 2014N/A1
Jun 2014N/A4
Sept 2014N/A39
Dec 2014N/A144
Mar 2015N/A155
Jun 2015N/A179
Sept 2015N/A189
Dec 2015N/A210

Total number of device types/product codes

Fiscal Year - All
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TimeTargetNumber
Mar 2014N/A208
Jun 2014N/A208
Sept 2014N/A208
Dec 2014N/A208
Mar 2015N/A208
Jun 2015N/A210
Sept 2015N/A210
Dec 2015N/A210

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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