| 1 | Total number of training events in the month | CDRH | N/A | Active | Key Center Director Measures |  |
| 2 | Total number of CDRH employees who completed training events in the month | CDRH | N/A | Active | Key Center Director Measures |  |
| 3 | Percent of CDRH intra- and inter-Office eConsults completed on time during the month | CDRH | N/A | Active | Key Center Director Measures |  |
| 4 | Total number of OCD employees who completed training events in the month | CDRH | Office of the Center Director | Active | Key Center Director Measures |  |
| 5 | Cumulative percent of guidance documents cleared by OCD | CDRH | Office of the Center Director | Active | Program Measures |  |
| 6 | Cumulative number of CDRH 2012 Strategic Priorities actions listed in the plan completed | CDRH | Office of the Center Director | Completed | Program Measures |  |
| 7 | Cumulative percent of guidance documents for which a final action was taken by CDRH | CDRH | Office of the Center Director | Completed | Program Measures |  |
| 8 | International Medical Device Regulators Forum | CDRH | Office of the Center Director | Completed | Key Projects |  |
| 9 | Total number of OMO employees who completed training events in the month | CDRH | Office of Management Operations | Active | Key Center Director Measures |  |
| 10 | Percent of CTRS-reporting employees who reported their time during the quarter | CDRH | Office of Management Operations | Active | Program Measures |  |
| 11 | Develop and Implement Revised CDRH Honor Awards Process | CDRH | Office of Management Operations | Active | Key Projects |  |
| 12 | Percent of PMAPs for new CDRH employees completed on time - within 30 days of arrival (DOA) - during the month | CDRH | Office of Management Operations | Completed | Program Measures |  |
| 13 | Total number of OCER employees who completed training events in the month | CDRH | Office of Communication, Education and Radiation Programs | Active | Key Center Director Measures |  |
| 14 | Percent of OCER intra- and inter-Office eConsults completed on time during the month | CDRH | Office of Communication, Education and Radiation Programs | Active | Key Center Director Measures |  |
| 15 | Percent of CDRH web documents posted within established time frames | CDRH | Office of Communication, Education and Radiation Programs | Active | Program Measures |  |
| 16 | Number of CDRH web pages updated during the month | CDRH | Office of Communication, Education and Radiation Programs | Active | Program Measures |  |
| 17 | Percent of eRadHealth submissions submitted electronically during the month | CDRH | Office of Communication, Education and Radiation Programs | Active | Program Measures |  |
| 18 | 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 | Completed | Program Measures |  |
| 19 | Percent of MQSA inspections completed within the 12-14 month requirement during the month | CDRH | Office of Communication, Education and Radiation Programs | Completed | Program Measures |  |
| 20 | Develop a CDRH Employee Resource Center | CDRH | Office of Communication, Education and Radiation Programs | Active | Key Projects |  |
| 21 | Develop a Life Cycle Approach to Employee Education | CDRH | Office of Communication, Education and Radiation Programs | Completed | Key Projects |  |
| 22 | Total number of OC employees who completed training events in the month | CDRH | Office of Compliance | Active | Key Center Director Measures |  |
| 23 | Percent of OC intra- and inter-Office eConsults completed on time during the month | CDRH | Office of Compliance | Active | Key Center Director Measures |  |
| 24 | Percent of recalls (I, II, and III) meeting OC timeframes classified during the month | CDRH | Office of Compliance | Active | Program Measures |  |
| 25 | Medical Device Single Audit Program (MDSAP) | CDRH | Office of Compliance | Active | Key Projects |  |
| 26 | Medical Device and Radiation-Emitting Product Recall Process Improvement Project | CDRH | Office of Compliance | Completed | Key Projects |  |
| 27 | 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 | Completed | Program Measures |  |
| 28 | Percent of CDRH 75/135-Day Supplement decisions made in 75/135 days or less during the month | CDRH | Office of Compliance | Completed | Program Measures |  |
| 29 | Total number of OSEL employees who completed training events in the month | CDRH | Office of Science and Engineering Laboratories | Active | Key Center Director Measures |  |
| 30 | Percent of OSEL intra- and inter-Office eConsults completed on time during the month | CDRH | Office of Science and Engineering Laboratories | Active | Key Center Director Measures |  |
| 31 | Number of OSEL-generated research papers about medical device related issues published during the month | CDRH | Office of Science and Engineering Laboratories | Active | Program Measures |  |
| 32 | 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 | Active | Program Measures |  |
| 33 | Number of technical reviews of new applications and data supporting requests for premarket approvals completed | CDRH | Office of Science and Engineering Laboratories | Active | Program Measures |  |
| 34 | Number of technical analyses of postmarket device problems and performance completed | CDRH | Office of Science and Engineering Laboratories | Active | Program Measures |  |
| 35 | 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 | Active | Key Projects |  |
| 36 | Total number of OSB employees who completed training events in the month | CDRH | Office of Surveillance and Biometrics | Active | Key Center Director Measures |  |
| 37 | Percent of OSB intra- and inter-Office eConsults completed on time during the month | CDRH | Office of Surveillance and Biometrics | Active | Key Center Director Measures |  |
| 38 | Percent of PAS decision letters completed within established time frames during the month | CDRH | Office of Surveillance and Biometrics | Active | Program Measures |  |
| 39 | Cumulative average number of MedSun reports submitted per hospital | CDRH | Office of Surveillance and Biometrics | Completed | Program Measures |  |
| 40 | Percent of death MDRs reviewed within 5 business days during the month | CDRH | Office of Surveillance and Biometrics | Active | Program Measures |  |
| 41 | Percent of “Code Blue” MDRs reviewed within 72 hours during the month | CDRH | Office of Surveillance and Biometrics | Active | Program Measures |  |
| 42 | Medical Device Epidemiology Network (MDEpiNET) | CDRH | Office of Surveillance and Biometrics | Active | Key Projects |  |
| 43 | Unique Device Identification Database (UDID) | CDRH | Office of Surveillance and Biometrics | Active | Key Projects |  |
| 44 | Total number of ODE employees who completed training events in the month | CDRH | Office of Device Evaluation | Active | Key Center Director Measures |  |
| 45 | Percent of ODE intra- and inter-Office eConsults completed on time during the month | CDRH | Office of Device Evaluation | Active | Key Center Director Measures |  |
| 46 | Total number of OIR employees who completed training events in the month | CDRH | Office of In Vitro Diagnostic Device Evaluation and Safety | Active | Key Center Director Measures |  |
| 47 | Percent of OIR intra- and inter-Office eConsults completed on time during the month | CDRH | Office of In Vitro Diagnostic Device Evaluation and Safety | Active | Key Center Director Measures |  |
| 48 | Percent of CDRH (ODE and OIR) 510(k) decisions meeting MDUFA goals during the month | CDRH | N/A | Active | Program Measures |  |
| 49 | Percent of ODE 510(k) decisions meeting MDUFA goals during the month | CDRH | Office of Device Evaluation | Active | Program Measures |  |
| 50 | Percent of OIR 510(k) decisions meeting MDUFA goals during the month | CDRH | Office of In Vitro Diagnostic Device Evaluation and Safety | Active | Program Measures |  |
| 51 | Percent of CDRH (ODE and OIR) 180-Day PMA Supplements decisions made in 180 days or less during the quarter | CDRH | N/A | Active | Program Measures |  |
| 52 | Percent of ODE 180-Day PMA Supplements decisions made in 180 days or less during the quarter | CDRH | Office of Device Evaluation | Active | Program Measures |  |
| 53 | Percent of OIR 180-Day PMA Supplements decisions made in 180 days or less during the quarter | CDRH | Office of In Vitro Diagnostic Device Evaluation and Safety | Active | Program Measures |  |
| 54 | Improve 510(k) Submission Quality | CDRH | Office of Device Evaluation | Active | Key Projects |  |
| 55 | Personalized Medicine | CDRH | Office of In Vitro Diagnostic Device Evaluation and Safety | Active | Key Projects |  |
| 56 | Percent of CDRH employees receiving training during the month | CDRH | N/A | Completed | Key Center Director Measures |  |
| 57 | Percent of OCD employees receiving training during the month | CDRH | Office of the Center Director | Completed | Key Center Director Measures |  |
| 58 | Percent of OMO employees receiving training during the month | CDRH | Office of Management Operations | Completed | Key Center Director Measures |  |
| 59 | Percent of CDRH inter-Office eConsults completed on time during the month | CDRH | N/A | Completed | Key Center Director Measures |  |
| 60 | Cumulative percent of CDRH 2011 Strategic Priorities actions listed in the plan completed | CDRH | Office of the Center Director | Completed | Program Measures |  |
| 61 | Cumulative percent of CDRH FY 2010 Strategic Priorities actions listed in the plan completed | CDRH | Office of the Center Director | Completed | Program Measures |  |
| 62 | Foster the Development of Medical Devices to Respond to Unmet Public Health Needs | CDRH | Office of the Center Director | Completed | Key Projects |  |
| 63 | Reduce Undelivered Orders Backlog | CDRH | Office of Management Operations | Completed | Key Projects |  |
| 64 | Make White Oak Facilities Assigned to CDRH More Workplace Friendly | CDRH | Office of Management Operations | Completed | Key Projects |  |
| 65 | Percent of OCER employees receiving training during the month | CDRH | Office of Communication, Education and Radiation Programs | Completed | Key Center Director Measures |  |
| 66 | Percent of OCER inter-Office eConsults completed on time during the month | CDRH | Office of Communication, Education and Radiation Programs | Completed | Key Center Director Measures |  |
| 67 | CDRH Transparency and Decision-Making | CDRH | Office of Communication, Education and Radiation Programs | Completed | Key Projects |  |
| 68 | Percent of OC employees receiving training during the month | CDRH | Office of Compliance | Completed | Key Center Director Measures |  |
| 69 | Percent of OC inter-Office eConsults completed on time during the month | CDRH | Office of Compliance | Completed | Key Center Director Measures |  |
| 70 | Compliance's Import Safety Initiative | CDRH | Office of Compliance | Completed | Key Projects |  |
| 71 | Number of scientific and technical training classes led by or organized by OSEL staff during the month | CDRH | Office of Science and Engineering Laboratories | Completed | Program Measures |  |
| 72 | Number of internal and external presentations by OSEL staff during the month | CDRH | Office of Science and Engineering Laboratories | Completed | Program Measures |  |
| 73 | Percent of actions listed in OSEL research plans completed on time during the month | CDRH | Office of Science and Engineering Laboratories | Completed | Program Measures |  |
| 74 | Percent of OSEL employees receiving training during the month | CDRH | Office of Science and Engineering Laboratories | Completed | Key Center Director Measures |  |
| 75 | Percent of OSEL inter-Office eConsults completed on time during the month | CDRH | Office of Science and Engineering Laboratories | Completed | Key Center Director Measures |  |
| 76 | Average impact factor of journals in which OSEL-generated research papers were published during the month | CDRH | Office of Science and Engineering Laboratories | Completed | Program Measures |  |
| 77 | Code Sharing of Device Related Software | CDRH | Office of Science and Engineering Laboratories | Completed | Key Projects |  |
| 78 | Electromagnetic Compatibility (EMC) of Medical Devices | CDRH | Office of Science and Engineering Laboratories | Completed | Key Projects |  |
| 79 | Percent of OSB employees receiving training during the month | CDRH | Office of Surveillance and Biometrics | Completed | Key Center Director Measures |  |
| 80 | Percent of OSB inter-Office eConsults completed on time during the month | CDRH | Office of Surveillance and Biometrics | Completed | Key Center Director Measures |  |
| 81 | Cumulative percent of PAS studies on publicly accessible PAS tracking website with expanded information abstracted, reviewed, and approved | CDRH | Office of Surveillance and Biometrics | Completed | Program Measures |  |
| 82 | Average number of MedSun reports submitted per hospital during the month | CDRH | Office of Surveillance and Biometrics | Completed | Program Measures |  |
| 83 | 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 | Completed | Program Measures |  |
| 84 | Percent of ODE employees receiving training during the month | CDRH | Office of Device Evaluation | Completed | Key Center Director Measures |  |
| 85 | 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 | Completed | Program Measures |  |
| 86 | Percent of OIVD employees receiving training during the month | CDRH | Office of In Vitro Diagnostic Device Evaluation and Safety | Completed | Key Center Director Measures |  |
| 87 | Percent of 510(k) IVD decision summaries posted on the web within the 45 day timeframe during the month | CDRH | Office of In Vitro Diagnostic Device Evaluation and Safety | Completed | Program Measures |  |
| 88 | Percent of ODE inter-Office eConsults completed on time during the month | CDRH | Office of Device Evaluation | Completed | Key Center Director Measures |  |
| 89 | Percent of OIVD inter-Office eConsults completed on time during the month | CDRH | Office of In Vitro Diagnostic Device Evaluation and Safety | Completed | Key Center Director Measures |  |
| 90 | Cumulative percent of approved 180-day PMA supplement review memos posted during the month | CDRH | Office of Device Evaluation | Completed | Program Measures |  |
| 91 | iReview | CDRH | Office of Device Evaluation | Completed | Key Projects |  |