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U.S. Department of Health and Human Services

About FDA

FDA-TRACK

The list below provides information on FDA’s performance measures and projects as aligned to FDA strategic priorities and program offices. This list enables you to view charts of performance data and progress on important projects and programs.

To view completed FDA-TRACK performance measures and projects view the Archive Index

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Results

Number of results: 104

ItemProgramOfficeStrategic PlanStrategic Goal/Area
1Cumulative percentage of FY14 IDE studies with full approval in two review cycles or lessCDRHAllCDRH Strategic PlanStrengthen the Clinical Trial Enterprise
2Cumulative percentage of FY15 IDE studies with full approval in two review cycles or lessCDRHAllCDRH Strategic PlanStrengthen the Clinical Trial Enterprise
3Percent of meeting offerings made within 10 days of IDE study disapproval decisionCDRHAllCDRH Strategic PlanStrengthen the Clinical Trial Enterprise
4Median number of days between receipt of IDE study and granting full approval decisions during the monthCDRHAllCDRH Strategic PlanStrengthen the Clinical Trial Enterprise
5Cumulative percentage of device types/product codes evaluatedCDRHAllCDRH Strategic PlanStrike the Right Balance Between Premarket and Postmarket Data Collection
6Percent of death MDRs reviewed within 5 business daysCDRHAllCDRH Strategic PlanStrike the Right Balance Between Premarket and Postmarket Data Collection
7 Percent of "Code Blue" MDRs reviewed within 72 hoursCDRHAllCDRH Strategic PlanStrike the Right Balance Between Premarket and Postmarket Data Collection
8Number of OSEL-generated research papers about medical device related issues published during the monthCDRHAllCDRH Strategic PlanStrike the Right Balance Between Premarket and Postmarket Data Collection
9Number of scientific and technical training classes and presentations (internal and external) by OSEL staff during the monthCDRHAllCDRH Strategic PlanStrike the Right Balance Between Premarket and Postmarket Data Collection
10Number of technical reviews of new applications and data supporting requests for premarket approvals completed during the monthCDRHAllCDRH Strategic PlanStrike the Right Balance Between Premarket and Postmarket Data Collection
11Number of scientific consults completed for various postmarket regulatory processesCDRHAllCDRH Strategic PlanStrike the Right Balance Between Premarket and Postmarket Data Collection
12Cumulative percent of satisfied customers at the end of the monthCDRHAllCDRH Strategic PlanProvide Excellent Customer Service
13Total number of training events in the monthCDRHAllCDRH Strategic PlanStrengthen Our Workforce and Workplace
14Total number of CDRH employees who completed training events in the monthCDRHAllCDRH Strategic PlanStrengthen Our Workforce and Workplace
15Percent of CDRH intra- and inter-Office eConsults completed on time during the monthCDRHAllCDRH Strategic PlanCross-Cutting Measure
16Total number of OCD employees who completed training events in the monthCDRHOffice of the Center DirectorCDRH Strategic PlanStrengthen Our Workforce and Workplace
17Cumulative percent of guidance documents cleared by OCDCDRHOffice of the Center DirectorCDRH Strategic PlanCross-Cutting Measure
18Cumulative number of CDRH 2013 Strategic Priorities actions listed in the plan completedCDRHOffice of the Center DirectorCDRH Strategic PlanCross-Cutting Measure
19Total number of OMO employees who completed training events in the monthCDRHOffice of Management OperationsCDRH Strategic PlanStrengthen Our Workforce and Workplace
20Percent of CTRS-reporting employees who reported their time during the quarterCDRHOffice of Management OperationsCDRH Strategic PlanCross-Cutting Measure
21Develop and Implement Revised CDRH Honor Awards ProcessCDRHOffice of Management OperationsCDRH Strategic PlanStrengthen Our Workforce and Workplace
22Total number of OCER employees who completed training events in the monthCDRHOffice of Communication, Education and Radiation ProgramsCDRH Strategic PlanStrengthen Our Workforce and Workplace
23Percent of OCER intra- and inter-Office eConsults completed on time during the monthCDRHOffice of Communication, Education and Radiation ProgramsCDRH Strategic PlanCross-Cutting Measure
24Percent of CDRH web documents posted within established time framesCDRHOffice of Communication, Education and Radiation ProgramsCDRH Strategic PlanEnhance Communication and Transparency
25Number of CDRH web pages updated during the monthCDRHOffice of Communication, Education and Radiation ProgramsCDRH Strategic PlanEnhance Communication and Transparency
26Develop a CDRH Employee Resource CenterCDRHOffice of Communication, Education and Radiation ProgramsCDRH Strategic PlanStrengthen Our Workforce and Workplace
27Total number of OC employees who completed training events in the monthCDRHOffice of ComplianceCDRH Strategic PlanStrengthen Our Workforce and Workplace
28Percent of OC intra- and inter-Office eConsults completed on time during the monthCDRHOffice of ComplianceCDRH Strategic PlanCross-Cutting Measure
29Percent of recalls (I, II, and III) meeting OC timeframes classified during the monthCDRHOffice of ComplianceCDRH Strategic PlanPatients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
30Medical Device Single Audit Program (MDSAP)CDRHOffice of ComplianceCDRH Strategic PlanDevices are Legally Marketed in the U.S. and Remain Safe, Effective, and of High-Quality
31Total number of OSEL employees who completed training events in the monthCDRHOffice of Science and Engineering LaboratoriesCDRH Strategic PlanStrengthen Our Workforce and Workplace
32Percent of OSEL intra- and inter-Office eConsults completed on time during the monthCDRHOffice of Science and Engineering LaboratoriesCDRH Strategic PlanCross-Cutting Measure
33Number of OSEL-generated research papers about medical device related issues published during the monthCDRHOffice of Science and Engineering LaboratoriesCDRH Strategic PlanPatients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
34Number of scientific and technical training classes and presentations (internal and external) by OSEL staff during the monthCDRHOffice of Science and Engineering LaboratoriesCDRH Strategic PlanPatients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
35Number of technical reviews of new applications and data supporting requests for premarket approvals completedCDRHOffice of Science and Engineering LaboratoriesCDRH Strategic PlanPatients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
36Number of technical analyses of postmarket device problems and performance completedCDRHOffice of Science and Engineering LaboratoriesCDRH Strategic PlanPatients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
37Improving the Use of Computational Fluid Dynamic (CFD) Techniques to Evaluate Performance and Blood Damage Safety in Medical DevicesCDRHOffice of Science and Engineering LaboratoriesCDRH Strategic PlanPatients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
38Total number of OSB employees who completed training events in the monthCDRHOffice of Surveillance and BiometricsCDRH Strategic PlanStrengthen Our Workforce and Workplace
39Percent of OSB intra- and inter-Office eConsults completed on time during the monthCDRHOffice of Surveillance and BiometricsCDRH Stratgic PlanCross-Cutting Measure
40Percent of PAS decision letters completed within established time frames during the monthCDRHOffice of Surveillance and BiometricsCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
41Percent of death MDRs reviewed within 5 business days during the monthCDRHOffice of Surveillance and BiometricsCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
42Percent of “Code Blue” MDRs reviewed within 72 hours during the monthCDRHOffice of Surveillance and BiometricsCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
43Unique Device Identification Database (UDID)CDRHOffice of Surveillance and BiometricsCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
44Total number of ODE employees who completed training events in the monthCDRHOffice of Device EvaluationCDRH Strategic PlanStrengthen Our Workforce and Workplace
45Percent of ODE intra- and inter-Office eConsults completed on time during the monthCDRHOffice of Device EvaluationCDRH Strategic PlanCross-Cutting Measure
46Total number of OIR employees who completed training events in the monthCDRHOffice of In Vitro Diagnostics and Radiological HealthCDRH Strategic PlanStrengthen Our Workforce and Workplace
47Percent of OIR intra- and inter-Office eConsults completed on time during the monthCDRHOffice of In Vitro Diagnostics and Radiological HealthCDRH Strategic PlanCross-Cutting Measure
48Percent of CDRH (ODE and OIR) 510(k) decisions meeting MDUFA goals during the monthCDRHPremarket OfficesCDRH Strategic PlanPatients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
49Percent of ODE 510(k) decisions meeting MDUFA goals during the monthCDRHOffice of Device EvaluationCDRH Strategic PlanPatients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
50Percent of OIR 510(k) decisions meeting MDUFA goals during the monthCDRHOffice of In Vitro Diagnostics and Radiological HealthCDRH Strategic PlanPatients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
51Percent of CDRH (ODE and OIR) 180-Day PMA Supplements decisions made in 180 days or less during the quarterCDRHPremarket OfficesCDRH Strategic PlanPatients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
52Percent of ODE 180-Day PMA Supplements decisions made in 180 days or less during the quarterCDRHOffice of Device EvaluationCDRH Strategic PlanPatients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
53Percent of OIR 180-Day PMA Supplements decisions made in 180 days or less during the quarterCDRHOffice of In Vitro Diagnostics and Radiological HealthCDRH Strategic PlanPatients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
54Improve 510(k) Submission QualityCDRHOffice of Device EvaluationCDRH Strategic PlanPatients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
55Percent of eRadHealth submissions submitted electronically during the monthCDRHOffice of In Vitro Diagnostics and Radiological HealthCDRH Strategic PlanThe U.S. is the World’s Leader in Regulatory Science, Medical Device Innovation and Manufacturing, and Radiation-Emitting Product Safety
56Personalized MedicineCDRHOffice of In Vitro Diagnostics and Radiological HealthCDRH Strategic PlanPatients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
57Percent of CDRH employees receiving training during the monthCDRHN/ACDRH Strategic PlanStrengthen Our Workforce and Workplace
58Percent of OCD employees receiving training during the monthCDRHOffice of the Center DirectorCDRH Strategic PlanStrengthen Our Workforce and Workplace
59Percent of PMAPs for new CDRH employees completed on time - within 30 days of arrival (DOA) - during the monthCDRHOffice of Management OperationsCDRH Strategic PlanStrengthen Our Workforce and Workplace
60Percent of OMO employees receiving training during the monthCDRHOffice of Management OperationsCDRH Strategic PlanStrengthen Our Workforce and Workplace
61Percent of CDRH inter-Office eConsults completed on time during the monthCDRHAllCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
62Cumulative percent of CDRH 2011 Strategic Priorities actions listed in the plan completedCDRHOffice of the Center DirectorCDRH Strategic PlanCross-Cutting Measure
63Cumulative percent of CDRH FY 2010 Strategic Priorities actions listed in the plan completedCDRHOffice of the Center DirectorCDRH Strategic PlanCross-Cutting Measure
64Foster the Development of Medical Devices to Respond to Unmet Public Health NeedsCDRHOffice of the Center DirectorCDRH Strategic PlanProactively Facilitate Innovation and Address Unmet Public Health Needs
65Cumulative number of CDRH 2012 Strategic Priorities actions listed in the plan completedCDRHOffice of the Center DirectorCDRH Strategic PlanCross-Cutting Measure
66Cumulative percent of guidance documents for which a final action was taken by CDRHCDRHOffice of the Center DirectorCDRH Strategic PlanCross-Cutting Measure
67International Medical Device Regulators ForumCDRHOffice of the Center DirectorCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
68Reduce Undelivered Orders BacklogCDRHOffice of Management OperationsCDRH Strategic PlanStrengthen Our Workforce and Workplace
69Make White Oak Facilities Assigned to CDRH More Workplace FriendlyCDRHOffice of Management OperationsCDRH Strategic PlanStrengthen Our Workforce and Workplace
70Percent of domestic mammography facilities inspected that were free of Level 1 (serious) inspection observations during the monthCDRHOffice of Communication, Education, and Radiation ProgramsCDRH Stratgic PlanFully Implement a Total Product Life Cycle Approach
71Percent of MQSA inspections completed within the 12-14 month requirement during the monthCDRHOffice of Communication, Education, and Radiation ProgramsCDRH Stratgic PlanFully Implement a Total Product Life Cycle Approach
72Develop a Life Cycle Approach to Employee EducationCDRHOffice of Communication, Education, and Radiation ProgramsCDRH Strategic PlanStrengthen Our Workforce and Workplace
73Percent of OCER employees receiving training during the monthCDRHOffice of Communication, Education, and Radiation ProgramsCDRH Strategic PlanStrengthen Our Workforce and Workplace
74Percent of OCER inter-Office eConsults completed on time during the monthCDRHOffice of Communication, Education, and Radiation ProgramsCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
75CDRH Transparency and Decision-MakingCDRHOffice of Communication, Education, and Radiation ProgramsCDRH Strategic PlanEnhance Communication and Transparency
76Medical Device and Radiation-Emitting Product Recall Process Improvement ProjectCDRHOffice of ComplianceCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
77CDRH 30-Day Notices completed on time, converted to 75/135-Day Supplements, or reviewed that "do not qualify as a 30-Day Notice" during the monthCDRHOffice of ComplianceCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
78Percent of CDRH 75/135-Day Supplement decisions made in 75/135 days or less during the monthCDRHOffice of ComplianceCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
79Percent of OC employees receiving training during the monthCDRHOffice of ComplianceCDRH Strategic PlanStrengthen Our Workforce and Workplace
80Percent of OC inter-Office eConsults completed on time during the monthCDRHOffice of ComplianceCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
81Compliance's Import Safety InitiativeCDRHOffice of ComplianceCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
82Number of scientific and technical training classes led by or organized by OSEL staff during the monthCDRHOffice of Science and Engineering LaboratoriesCDRH Strategic PlanStrengthen Our Workforce and Workplace
83Number of internal and external presentations by OSEL staff during the monthCDRHOffice of Science and Engineering LaboratoriesCDRH Stratgic PlanFully Implement a Total Product Life Cycle Approach
84Percent of actions listed in OSEL research plans completed on time during the monthCDRHOffice of Science and Engineering LaboratoriesCDRH Stratgic PlanFully Implement a Total Product Life Cycle Approach
85Percent of OSEL employees receiving training during the monthCDRHOffice of Science and Engineering LaboratoriesCDRH Strategic PlanStrengthen Our Workforce and Workplace
86Percent of OSEL inter-Office eConsults completed on time during the monthCDRHOffice of Science and Engineering LaboratoriesCDRH Stratgic PlanFully Implement a Total Product Life Cycle Approach
87Average impact factor of journals in which OSEL-generated research papers were published during the monthCDRHOffice of Science and Engineering LaboratoriesCDRH Stratgic PlanFully Implement a Total Product Life Cycle Approach
88Code Sharing of Device Related SoftwareCDRHOffice of Science and Engineering LaboratoriesCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
89Electromagnetic Compatibility (EMC) of Medical DevicesCDRHOffice of Science and Engineering LaboratoriesCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
90Cumulative average number of MedSun reports submitted per hospitalCDRHOffice of Surveillance and BiometricsCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
91Percent of OSB employees receiving training during the monthCDRHOffice of Surveillance and BiometricsCDRH Strategic PlanStrengthen Our Workforce and Workplace
92Percent of OSB inter-Office eConsults completed on time during the monthCDRHOffice of Surveillance and BiometricsCDRH Stratgic PlanFully Implement a Total Product Life Cycle Approach
93Cumulative percent of PAS studies on publicly accessible PAS tracking website with expanded information abstracted, reviewed, and approvedCDRHOffice of Surveillance and BiometricsCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
94Average number of MedSun reports submitted per hospital during the monthCDRHOffice of Surveillance and BiometricsCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
95Percent of MedSun hospitals (in program for at least 11 months) which have submitted at least 3 reports in previous 12 monthsCDRHOffice of Surveillance and BiometricsCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
96Medical Device Epidemiology Network (MDEpiNET)CDRHOffice of Surveillance and BiometricsCDRH Strategic PlanU.S. Post-Market Surveillance Quickly Identifies Poorly Performing Devices, Accurately Characterizes Real-World Performance, and Facilitates Device Approval or Clearance
97Percent of ODE employees receiving training during the monthCDRHOffice of Device EvaluationCDRH Strategic PlanStrengthen Our Workforce and Workplace
98Percent of 180-day PMA supplement summary review memos posted on the web within 60 days from approval to posting during the monthCDRHOffice of Device EvaluationCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
99Percent of OIVD employees receiving training during the monthCDRHOffice of In Vitro Diagnostics and Radiological HealthCDRH Strategic PlanStrengthen Our Workforce and Workplace
100Percent of 510(k) IVD decision summaries posted on the web within the 45 day timeframe during the monthCDRHOffice of In Vitro Diagnostics and Radiological HealthCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
101Percent of ODE inter-Office eConsults completed on time during the monthCDRHOffice of Device EvaluationCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
102Percent of OIVD inter-Office eConsults completed on time during the monthCDRHOffice of In Vitro Diagnostics and Radiological HealthCDRH Stratgic PlanFully Implement a Total Product Life Cycle Approach
103Cumulative percent of approved 180-day PMA supplement review memos posted during the monthCDRHOffice of Device EvaluationCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach
104iReviewCDRHOffice of Device EvaluationCDRH Strategic PlanFully Implement a Total Product Life Cycle Approach

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 in the Archive Index may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.