About FDA
Percent of meeting offerings made within 10 days of IDE study disapproval decision
Dictionary: CDRH 2014-2015 Strategic Priorty: Strengthen the Clinical Trial Enterprise
Goal: Improve the efficiency, consistency, and predictability of the IDE process to reduce the time and number of cycles needed to reach appropriate IDE full approval for medical devices, in general, and for devices of public health importance, in particular
FDA implemented process changes to the Investigational Device Exemption (IDE) program, consistent with FDASIA. These process changes proposed additional program modification to allow earlier and more efficient clinical study enrollment. This program measure gauges the percentage of sponsors who were offered a teleconference or in-person meeting within 10 business days of the IDE disapproval decision.
The final target date for this measure was 6/30/2015. Data for this measure will no longer be updated.
Information is current as of August 26, 2015
Fiscal Year - 2015
Time | Target | Percent |
---|---|---|
Oct 2014 | 100% | 100% |
Nov 2014 | 100% | 100% |
Dec 2014 | 100% | 100% |
Jan 2015 | 100% | 100% |
Feb 2015 | 100% | 100% |
Mar 2015 | 100% | 100% |
Apr 2015 | 100% | 100% |
May 2015 | 100% | 100% |
Jun 2015 | 100% | 100% |
FY 2015 Cumulative Percent: 100%
Footnotes
- CDRH created this new measure and began collecting data in March 2014. Therefore, FY14 will only include 7 months of data.
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.