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U.S. Department of Health and Human Services

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FDA-TRACK Archive

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 current FDA-TRACK performance measures and projects view the Active Index

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Results

Number of results:108

ItemProgramOfficeFY CompletedStrategic PlanStrategic Goal/Area
1 Cumulative percentage of FY14 IDE studies with full approval in two review cycles or less CDRH All CDRH Strategic Plan Strengthen the Clinical Trial Enterprise
2 Cumulative percentage of FY15 IDE studies with full approval in two review cycles or less CDRH All CDRH Strategic Plan Strengthen the Clinical Trial Enterprise
3 Median number of days between receipt of FY14 IDE study and granting full approval decisions during the month CDRH All CDRH Strategic Plan Strengthen the Clinical Trial Enterprise
4 Median number of days between receipt of FY15 IDE study and granting full approval decisions during the month CDRH All CDRH Strategic Plan Strengthen the Clinical Trial Enterprise
5 Percent of meeting offerings made within 10 days of IDE study disapproval decision CDRH All CDRH Strategic Plan Strengthen the Clinical Trial Enterprise
6 Cumulative number of FY15 early feasibility/first-in-human IDE studies submitted to each premarket division compared to FY13 during the fiscal year CDRH All CDRH Strategic Plan Strengthen the Clinical Trial Enterprise
7 Cumulative percentage of device types/product codes evaluated CDRH All CDRH Strategic Plan Strike the Right Balance Between Premarket and Postmarket Data Collection
8 CDRH PMA Supplements MDUFA CDRH All CDRH Strategic Plan Strike the Right Balance Between Premarket and Postmarket Data Collection
9 CDRH 510(k) MDUFA CDRH All CDRH Strategic Plan Strike the Right Balance Between Premarket and Postmarket Data Collection
10 Percent of death MDRs reviewed within 5 business days CDRH All CDRH Strategic Plan Strike the Right Balance Between Premarket and Postmarket Data Collection
11 Percent of "Code Blue" MDRs reviewed within 72 hours CDRH All CDRH Strategic Plan Strike the Right Balance Between Premarket and Postmarket Data Collection
12 Number of OSEL-generated research papers about medical device related issues published during the month CDRH All CDRH Strategic Plan Strike the Right Balance Between Premarket and Postmarket Data Collection
13 Number of scientific and technical training classes and presentations (internal and external) by OSEL staff during the month CDRH All CDRH Strategic Plan Strike the Right Balance Between Premarket and Postmarket Data Collection
14 Number of technical reviews of new applications and data supporting requests for premarket approvals completed during the month CDRH All CDRH Strategic Plan Strike the Right Balance Between Premarket and Postmarket Data Collection
15 Number of scientific consults completed for various postmarket regulatory processes CDRH All CDRH Strategic Plan Strike the Right Balance Between Premarket and Postmarket Data Collection
16 Cumulative percent of satisfied customers at the end of the month CDRH All CDRH Strategic Plan Provide Excellent Customer Service
17 Total number of training events in the month CDRH All 2013 CDRH Strategic Plan Strengthen Our Workforce and Workplace
18 Total number of CDRH employees who completed training events in the month CDRH All 2013 CDRH Strategic Plan Strengthen Our Workforce and Workplace
19 Percent of CDRH intra- and inter-Office eConsults completed on time during the month CDRH All 2013 CDRH Strategic Plan Cross-Cutting Measure
20 Total number of OCD employees who completed training events in the month CDRH Office of the Center Director 2013 CDRH Strategic Plan Strengthen Our Workforce and Workplace
21 Cumulative percent of guidance documents cleared by OCD CDRH Office of the Center Director 2013 CDRH Strategic Plan Cross-Cutting Measure
22 Cumulative number of CDRH 2013 Strategic Priorities actions listed in the plan completed CDRH Office of the Center Director 2013 CDRH Strategic Plan Cross-Cutting Measure
23 Total number of OMO employees who completed training events in the month CDRH Office of Management Operations CDRH Strategic Plan Strengthen Our Workforce and Workplace
24 Percent of CTRS-reporting employees who reported their time during the quarter CDRH Office of Management Operations CDRH Strategic Plan Cross-Cutting Measure
25 Develop and Implement Revised CDRH Honor Awards Process CDRH Office of Management Operations CDRH Strategic Plan Strengthen Our Workforce and Workplace
26 Total number of OCER employees who completed training events in the month CDRH Office of Communication, Education and Radiation Programs CDRH Strategic Plan Strengthen Our Workforce and Workplace
27 Percent of OCER intra- and inter-Office eConsults completed on time during the month CDRH Office of Communication, Education and Radiation Programs CDRH Strategic Plan Cross-Cutting Measure
28 Percent of CDRH web documents posted within established time frames CDRH Office of Communication, Education and Radiation Programs CDRH Strategic Plan Enhance Communication and Transparency
29 Number of CDRH web pages updated during the month CDRH Office of Communication, Education and Radiation Programs CDRH Strategic Plan Enhance Communication and Transparency
30 Develop a CDRH Employee Resource Center CDRH Office of Communication, Education and Radiation Programs 2013 CDRH Strategic Plan Strengthen Our Workforce and Workplace
31 Total number of OC employees who completed training events in the month CDRH Office of Compliance CDRH Strategic Plan Strengthen Our Workforce and Workplace
32 Percent of OC intra- and inter-Office eConsults completed on time during the month CDRH Office of Compliance CDRH Strategic Plan Cross-Cutting Measure
33 Percent of recalls (I, II, and III) meeting OC timeframes classified during the month CDRH Office of Compliance CDRH Strategic Plan Patients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
34 Medical Device Single Audit Program (MDSAP) CDRH Office of Compliance CDRH Strategic Plan Devices are Legally Marketed in the U.S. and Remain Safe, Effective, and of High-Quality
35 Total number of OSEL employees who completed training events in the month CDRH Office of Science and Engineering Laboratories CDRH Strategic Plan Strengthen Our Workforce and Workplace
36 Percent of OSEL intra- and inter-Office eConsults completed on time during the month CDRH Office of Science and Engineering Laboratories CDRH Strategic Plan Cross-Cutting Measure
37 Number of OSEL-generated research papers about medical device related issues published during the month CDRH Office of Science and Engineering Laboratories CDRH Strategic Plan Patients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
38 Number of scientific and technical training classes and presentations (internal and external) by OSEL staff during the month CDRH Office of Science and Engineering Laboratories CDRH Strategic Plan Patients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
39 Number of technical reviews of new applications and data supporting requests for premarket approvals completed CDRH Office of Science and Engineering Laboratories CDRH Strategic Plan Patients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
40 Number of technical analyses of postmarket device problems and performance completed CDRH Office of Science and Engineering Laboratories CDRH Strategic Plan Patients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
41 Improving the Use of Computational Fluid Dynamic (CFD) Techniques to Evaluate Performance and Blood Damage Safety in Medical Devices CDRH Office of Science and Engineering Laboratories CDRH Strategic Plan Patients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
42 Total number of OSB employees who completed training events in the month CDRH Office of Surveillance and Biometrics CDRH Strategic Plan Strengthen Our Workforce and Workplace
43 Percent of OSB intra- and inter-Office eConsults completed on time during the month CDRH Office of Surveillance and Biometrics CDRH Stratgic Plan Cross-Cutting Measure
44 Percent of PAS decision letters completed within established time frames during the month CDRH Office of Surveillance and Biometrics CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
45 Percent of death MDRs reviewed within 5 business days during the month CDRH Office of Surveillance and Biometrics CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
46 Percent of “Code Blue” MDRs reviewed within 72 hours during the month CDRH Office of Surveillance and Biometrics CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
47 Unique Device Identification Database (UDID) CDRH Office of Surveillance and Biometrics CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
48 Total number of ODE employees who completed training events in the month CDRH Office of Device Evaluation CDRH Strategic Plan Strengthen Our Workforce and Workplace
49 Percent of ODE intra- and inter-Office eConsults completed on time during the month CDRH Office of Device Evaluation CDRH Strategic Plan Cross-Cutting Measure
50 Total number of OIR employees who completed training events in the month CDRH Office of In Vitro Diagnostics and Radiological Health CDRH Strategic Plan Strengthen Our Workforce and Workplace
51 Percent of OIR intra- and inter-Office eConsults completed on time during the month CDRH Office of In Vitro Diagnostics and Radiological Health CDRH Strategic Plan Cross-Cutting Measure
52 Percent of CDRH (ODE and OIR) 510(k) decisions meeting MDUFA goals during the month CDRH Premarket Offices CDRH Strategic Plan Patients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
53 Percent of ODE 510(k) decisions meeting MDUFA goals during the month CDRH Office of Device Evaluation CDRH Strategic Plan Patients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
54 Percent of OIR 510(k) decisions meeting MDUFA goals during the month CDRH Office of In Vitro Diagnostics and Radiological Health CDRH Strategic Plan Patients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
55 Percent of CDRH (ODE and OIR) 180-Day PMA Supplements decisions made in 180 days or less during the quarter CDRH Premarket Offices CDRH Strategic Plan Patients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
56 Percent of ODE 180-Day PMA Supplements decisions made in 180 days or less during the quarter CDRH Office of Device Evaluation CDRH Strategic Plan Patients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
57 Percent of OIR 180-Day PMA Supplements decisions made in 180 days or less during the quarter CDRH Office of In Vitro Diagnostics and Radiological Health CDRH Strategic Plan Patients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
58 Improve 510(k) Submission Quality CDRH Office of Device Evaluation 2013 CDRH Strategic Plan Patients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
59 Percent of eRadHealth submissions submitted electronically during the month CDRH Office of In Vitro Diagnostics and Radiological Health CDRH Strategic Plan The U.S. is the World’s Leader in Regulatory Science, Medical Device Innovation and Manufacturing, and Radiation-Emitting Product Safety
60 Personalized Medicine CDRH Office of In Vitro Diagnostics and Radiological Health CDRH Strategic Plan Patients in the U.S. have Access to High-Quality, Safe, and Effective Medical Devices of Public Health Importance First in the World
61 Percent of CDRH employees receiving training during the month CDRH N/A 2010 CDRH Strategic Plan Strengthen Our Workforce and Workplace
62 Percent of OCD employees receiving training during the month CDRH Office of the Center Director 2010 CDRH Strategic Plan Strengthen Our Workforce and Workplace
63 Percent of PMAPs for new CDRH employees completed on time - within 30 days of arrival (DOA) - during the month CDRH Office of Management Operations 2012 CDRH Strategic Plan Strengthen Our Workforce and Workplace
64 Percent of OMO employees receiving training during the month CDRH Office of Management Operations 2010 CDRH Strategic Plan Strengthen Our Workforce and Workplace
65 Percent of CDRH inter-Office eConsults completed on time during the month CDRH All 2010 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
66 Cumulative percent of CDRH 2011 Strategic Priorities actions listed in the plan completed CDRH Office of the Center Director 2012 CDRH Strategic Plan Cross-Cutting Measure
67 Cumulative percent of CDRH FY 2010 Strategic Priorities actions listed in the plan completed CDRH Office of the Center Director 2010 CDRH Strategic Plan Cross-Cutting Measure
68 Foster the Development of Medical Devices to Respond to Unmet Public Health Needs CDRH Office of the Center Director 2011 CDRH Strategic Plan Proactively Facilitate Innovation and Address Unmet Public Health Needs
69 Cumulative number of CDRH 2012 Strategic Priorities actions listed in the plan completed CDRH Office of the Center Director 2012 CDRH Strategic Plan Cross-Cutting Measure
70 Cumulative percent of guidance documents for which a final action was taken by CDRH CDRH Office of the Center Director 2012 CDRH Strategic Plan Cross-Cutting Measure
71 International Medical Device Regulators Forum CDRH Office of the Center Director 2012 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
72 Reduce Undelivered Orders Backlog CDRH Office of Management Operations 2012 CDRH Strategic Plan Strengthen Our Workforce and Workplace
73 Make White Oak Facilities Assigned to CDRH More Workplace Friendly CDRH Office of Management Operations 2011 CDRH Strategic Plan Strengthen Our Workforce and Workplace
74 Percent of domestic mammography facilities inspected that were free of Level 1 (serious) inspection observations during the month CDRH Office of Communication, Education, and Radiation Programs 2012 CDRH Stratgic Plan Fully Implement a Total Product Life Cycle Approach
75 Percent of MQSA inspections completed within the 12-14 month requirement during the month CDRH Office of Communication, Education, and Radiation Programs 2012 CDRH Stratgic Plan Fully Implement a Total Product Life Cycle Approach
76 Develop a Life Cycle Approach to Employee Education CDRH Office of Communication, Education, and Radiation Programs 2012 CDRH Strategic Plan Strengthen Our Workforce and Workplace
77 Percent of OCER employees receiving training during the month CDRH Office of Communication, Education, and Radiation Programs 2010 CDRH Strategic Plan Strengthen Our Workforce and Workplace
78 Percent of OCER inter-Office eConsults completed on time during the month CDRH Office of Communication, Education, and Radiation Programs 2010 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
79 CDRH Transparency and Decision-Making CDRH Office of Communication, Education, and Radiation Programs 2011 CDRH Strategic Plan Enhance Communication and Transparency
80 Medical Device and Radiation-Emitting Product Recall Process Improvement Project CDRH Office of Compliance 2012 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
81 CDRH 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 month CDRH Office of Compliance 2012 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
82 Percent of CDRH 75/135-Day Supplement decisions made in 75/135 days or less during the month CDRH Office of Compliance 2012 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
83 Percent of OC employees receiving training during the month CDRH Office of Compliance 2010 CDRH Strategic Plan Strengthen Our Workforce and Workplace
84 Percent of OC inter-Office eConsults completed on time during the month CDRH Office of Compliance 2010 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
85 Compliance's Import Safety Initiative CDRH Office of Compliance 2011 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
86 Number of scientific and technical training classes led by or organized by OSEL staff during the month CDRH Office of Science and Engineering Laboratories 2011 CDRH Strategic Plan Strengthen Our Workforce and Workplace
87 Number of internal and external presentations by OSEL staff during the month CDRH Office of Science and Engineering Laboratories 2011 CDRH Stratgic Plan Fully Implement a Total Product Life Cycle Approach
88 Percent of actions listed in OSEL research plans completed on time during the month CDRH Office of Science and Engineering Laboratories 2011 CDRH Stratgic Plan Fully Implement a Total Product Life Cycle Approach
89 Percent of OSEL employees receiving training during the month CDRH Office of Science and Engineering Laboratories 2010 CDRH Strategic Plan Strengthen Our Workforce and Workplace
90 Percent of OSEL inter-Office eConsults completed on time during the month CDRH Office of Science and Engineering Laboratories 2010 CDRH Stratgic Plan Fully Implement a Total Product Life Cycle Approach
91 Average impact factor of journals in which OSEL-generated research papers were published during the month CDRH Office of Science and Engineering Laboratories 2010 CDRH Stratgic Plan Fully Implement a Total Product Life Cycle Approach
92 Code Sharing of Device Related Software CDRH Office of Science and Engineering Laboratories 2010 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
93 Electromagnetic Compatibility (EMC) of Medical Devices CDRH Office of Science and Engineering Laboratories 2012 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
94 Cumulative average number of MedSun reports submitted per hospital CDRH Office of Surveillance and Biometrics 2012 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
95 Percent of OSB employees receiving training during the month CDRH Office of Surveillance and Biometrics 2010 CDRH Strategic Plan Strengthen Our Workforce and Workplace
96 Percent of OSB inter-Office eConsults completed on time during the month CDRH Office of Surveillance and Biometrics 2010 CDRH Stratgic Plan Fully Implement a Total Product Life Cycle Approach
97 Cumulative percent of PAS studies on publicly accessible PAS tracking website with expanded information abstracted, reviewed, and approved CDRH Office of Surveillance and Biometrics 2010 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
98 Average number of MedSun reports submitted per hospital during the month CDRH Office of Surveillance and Biometrics 2011 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
99 Percent of MedSun hospitals (in program for at least 11 months) which have submitted at least 3 reports in previous 12 months CDRH Office of Surveillance and Biometrics 2011 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
100 Medical Device Epidemiology Network (MDEpiNET) CDRH Office of Surveillance and Biometrics 2013 CDRH Strategic Plan U.S. Post-Market Surveillance Quickly Identifies Poorly Performing Devices, Accurately Characterizes Real-World Performance, and Facilitates Device Approval or Clearance
101 Percent of ODE employees receiving training during the month CDRH Office of Device Evaluation 2010 CDRH Strategic Plan Strengthen Our Workforce and Workplace
102 Percent of 180-day PMA supplement summary review memos posted on the web within 60 days from approval to posting during the month CDRH Office of Device Evaluation 2012 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
103 Percent of OIVD employees receiving training during the month CDRH Office of In Vitro Diagnostics and Radiological Health 2010 CDRH Strategic Plan Strengthen Our Workforce and Workplace
104 Percent of 510(k) IVD decision summaries posted on the web within the 45 day timeframe during the month CDRH Office of In Vitro Diagnostics and Radiological Health 2012 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
105 Percent of ODE inter-Office eConsults completed on time during the month CDRH Office of Device Evaluation 2010 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
106 Percent of OIVD inter-Office eConsults completed on time during the month CDRH Office of In Vitro Diagnostics and Radiological Health 2010 CDRH Stratgic Plan Fully Implement a Total Product Life Cycle Approach
107 Cumulative percent of approved 180-day PMA supplement review memos posted during the month CDRH Office of Device Evaluation 2010 CDRH Strategic Plan Fully Implement a Total Product Life Cycle Approach
108 iReview CDRH Office of Device Evaluation 2010 CDRH Strategic Plan Fully 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.


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