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Medical Devices and Radiological Health Performance Detail FY 2012 OPA

Table of Contents FY 2012 OPA

Long Term Objective: Advance Medical Device Safety and Effectiveness

 

Measure

FY

Target

Result

253203: Percentage of received Original Premarket Approval (PMA), Panel-track PMA Supplement, and Premarket Report Submissions reviewed and decided upon within 180 and 295 days. (Outcome)

2012

50% in 180 days and 60% in 295 days

Jan 31, 2014

2011

50% in 180 days and 70% in 295 days

Jan 31, 2013

2010

60% in 180 days and 90% in 295 days

Jan 31, 2012

2009

60% in 180 days and 90% in 295 days

86% of 28 in 180 days and 93% of 28 in 295 days

(Target Exceeded)

2008

60% in 180 days and 90% in 295 days

68% of 33 in 180 days and 89% of 33 in 295 days

(Target Not Met)

2007

90% in 320 days

96% of 33
(Target Exceeded)

253204: Percentage of 180 day PMA supplements reviewed and decided upon within 180 and 210 days. (Outcome)

2012

75% in 180 days and 85% in 210 days

Jan 31, 2014

2011

80% in 180 days and 90% in 210 days

Jan 31, 2013

2010

85% in 180 days and 95% in 210 days

Jan 31, 2012

2009

85% in 180 days and 95% in 210 days

93% of 153 in 180 days and 97% of 153 in 210 days

(Target Exceeded)

2008

85% in 180 days and 95% in 210 days

91% of 170 in 180 days

and 96% of 170 in 210 days

(Target Exceeded)

2007

90% in 180 days

97% of 132
(Target Exceeded)

253205: Percentage of 510(k)s (Premarket Notifications) reviewed and decided upon within 90 and 150 days. (Outcome)

2012

75% in 90 days and 80% in 150 days

Jan 31, 2014

2011

85% in 90 days and 93% in 150 days

Jan 31, 2013

2010

90% in 90 days and 98% in 150 days

Jan 31, 2012

2009

90% in 90 days and 98% in 150 days

91% of 3,324 in 90 days and

98% of 3,324 in 150 days

(Target Exceeded)

2008

90% in 90 days and 98% in 150 days

94% of 3,255 in 90 days and

99% of 3,255 in 150 days

(Target Exceeded)

2007

80% in 90 days

92% of 3,531
(Target Exceeded)

253201: Number of Medical Device Bioresearch Monitoring (BIMO) inspections. (Output)

2012

300

December, 2012

2011

300

December, 2011

2010

300

392

(Target Exceeded)

2009

300

305

(Target Exceeded)

2008

300

301
(Target Exceeded)

2007

295

323
(Target Exceeded)

MDUFMA, and MDUFMA as amended review goals (Goals 253203, 253204, and 153205) are based on FDA review time only, and do not include time that elapses when the sponsor is responding to questions or issues raised by FDA.  This means that FDA cannot determine exactly when all the applications in a review cohort will be completed.  The actual results reported for this goal are as of the times noted, and as the final applications in the cohort are resolved, small changes to previously reported results may occur.

 

Measure

Data Source

Data Validation

253203
253204

253205
253201

CDRH Premarket Tracking System and Receipt Cohorts and Field Data Systems.

To help ensure Agency consistency in tracking and reporting Premarket activities, CDRH utilizes the Premarket Tracking System, which contains various types of data taken directly from the Premarket submissions. FDA employs certain conventions for monitoring and reporting performance; among these are groupings of Premarket submissions into decision and receipt cohorts. Decision cohorts are groupings of submissions upon which a decision was made within a specified time frame, while receipt cohorts are groupings of submissions that were received within a specified time frame. The Premarket performance goals are based on receipt cohorts. Final data for receipt cohorts are usually not available at the end of the submission year. Because the review of an application received on the last day of the submission year, e.g., a PMA with 180 day time frame, may not be completed for at least 6 months or longer, final data for the submission or goal year may not be available for up to a year or more after the end of the goal year.

 

Measure

FY

Target

Result

252201: The minimum number of reports per year that 80 percent of MedSun hospitals, enrolled for at least 11 months in the program will submit. (Outcome)

2012

3

December 31, 2012

2011

3

December 31, 2011

2010

3

3

(Target Met)

2009

Ensure the active participation of 95% of MedSun facilities in FY 2009 (at least 1 report)

1 Report Minimum

by 98% of Sites

(Target Exceeded)

2008

Ensure the active participation of 95% of MedSun facilities in FY 2009 (at least 1 report)

1 Report Minimum

 by 98% of Sites

 (Target Exceeded)

2007

Ensure the active participation of 90% of MedSun facilities in FY 2009 (at least 1 report)

1 Report Minimum

 by 90% of Sites

 (Target Met)

252202: By 2013, enroll 80% of the top 15 MDR reporters by volume in the voluntary eMDR (Medical Device Reporting) program.  (Outcome)

2012

73%

December 2012

2011

67%

December 2011

2010

40%

47%

(Target Exceeded)

2009

N/A

25%

(Historical Actual)

2008

N/A

13%

(Historical Actual)

2007

N/A

N/A

 

Measure

Data Source

Data Validation

252201

252202

CDRH Adverse Events Reports

FDA’s adverse event reporting system’s newest component is the Medical Device Surveillance Network (MedSun) program. MedSun is an initiative designed both to educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events, medical errors and other problems to FDA and/or the manufacturer, and to ensure that new safety information is rapidly communicated to the medical community thereby improving patient care.

 

Measure

FY

Target

Result

254202: Increase percentage of time CDRH meets the targeted deadline of 45 working days to review GMP information and issue Device Warning Letters. (Output)

2012

75%

December 2012

2011

75%

December 2011

2010

90%

66%

(Target Not Met)

2009

N/A

68%

(Historical Actual)

2008

N/A

53%

(Historical Actual)

2007

N/A

N/A

254201: Number of domestic and foreign Class II and Class III device inspections.   (Output)

2012

1,515

December, 2012

2011

1,445

December, 2011

2010

1,365

1,659

(Target Exceeded)

2009

1,340

1,471

(Target Exceeded)

2008

1,270

1,431
(Target Exceeded)

2007

1,195

1,468
(Target Exceeded)

254101: Percentage of an estimated 8,700 domestic mammography facilities that meet inspection standards, with less than 3% with Level I (serious) problems. (Outcome)

2012

97%

December 31, 2012

2011

97%

December 31, 2011

2010

97%

97%

(Target Met)

2009

97%

97%

(Target Met)

2008

97%

97%
(Target Met)

2007

97%

97%
(Target Met)

 

Measure

Data Source

Data Validation

254202

Center Tracking System and Mission Accomplishment and Regulatory Compliance Services (MARCS) system.

CDRH uses the Center Tracking  System and the Mission Accomplishment and Regulatory Compliance Services (MARCS) system to track GMP Warning Letters and timeframes.

254201

Field Data Systems.

ORA uses two main information technology systems to track and verify field performance goal activities: the Field Accomplishments and Compliance Tracking System (FACTS) and the Operational and Administrative System Import Support (OASIS). FACTS includes data on the number of inspections; field exams; sample collections; laboratory analyses; and, the time spent on each. OASIS, which is coordinated with U.S. Customs and Border Protection, provides data on what FDA regulated products are being imported as well as where they are arriving. It also provides information on compliance actions related to imports. FDA is currently developing the Mission Accomplishment and Regulatory Compliance Services (MARCS) system. MARCS will incorporate the capabilities of these two field legacy systems and include additional functionality.

254101

Mammography Program Reporting and Information System (MPRIS)

The Mammography Program Reporting and Information System (MPRIS) is a set of applications used to support all aspects of the FDA implementation of the Mammography Quality Standards Act of 1992. This includes the collection, processing and maintenance of data on mammography facility accreditation and certification, FDA inspections and compliance actions. MPRIS is envisioned as a centralized repository of information that supports FDA’s mission to improve the quality of mammography and improves the overall quality, reliability, integrity, and accessibility of facility certification, inspection, and compliance data by eliminating multiple versions of the data while expanding and automating data edits, validation, and security of a single integrated database.

 


 

Measure

FY

Target

Result

252101: Number of technical analyses of postmarket device problems and performance.

(Output)

2012

125

December 31, 2012

2011

125

December 31, 2011

2010

125

127

(Target Exceeded)

2009

N/A

110

(Historical Actual)

2008

N/A

70

(Historical Actual)

2007

N/A

N/A

253207: Number of technical reviews of new applications and data supporting requests for premarket approvals.

(Output)

2012

1,175

December 31, 2012

2011

1,175

December 31, 2011

2010

1,175

1,429

(Target Exceeded)

2009

N/A

1,128

(Historical Actual)

2008

N/A

956

(Historical Actual)

2007

N/A

N/A

 



Measure

Data Source

Data Validation

252101

253207

CDRH E-Consults and Office of Science and Engineering Laboratories Productivity database.

Technical Analysis and Reviews are tracked and verified through the CDRH E-Consults and Office of Science and Engineering Laboratories databases. 

 

1.      Percentage of received Original Premarket Approval (PMA), Panel-track PMA Supplement, and Premarket Report Submissions reviewed and decided upon within 180 and 295 days. (253203)

 

Context:  Complete decision constitutes the comprehensive review of the application package initially received by FDA and FDA’s decision letter.  PMAs involve potentially high-risk devices with the highest likelihood of significantly improving the treatment of patients.  The steps taken in MDUFMA and MDUFA II to reduce approval times for PMA applications are expected to reduce approval times for all filed applications. However, some applications may not ultimately meet FDA’s standards for safety and effectiveness, and performance measures based on all applications will take more time to observe.  MDUFA II performance targets for Original PMA applications will be to arrive at a decision on 60% of Original PMA applications within 180 days and 90% within 295 days. 

 

Performance:  CDRH is currently exceeding performance for tier 1 of the FY 2009 target by making decisions on 86% of 28 Original PMA applications in 180 days and 93% of 33 Original PMA applications in 295 days.  The current baseline for FDA decision time for standard PMAs is 295 days. The cohort remains open. The FY 2010 performance data for this goal will not be available until January 2012. If the number of reviewers remains constant, CDRH expects performance levels to decrease due to the increasing complexity of PMAs.

2.      Percentage of 180 day PMA supplements reviewed and decided upon within 180 and 210 days. (253204)  

 

Context:  Complete decision constitutes the comprehensive review of the application package initially received by FDA and FDA’s decision letter.  A decision will result in one of the following designations for each application: approval, approvable, approvable pending GMP inspection, not approvable, denial.  PMAs involve potentially high-risk devices that have the highest likelihood of significantly improving the treatment of patients.  Supplemental applications are generally submitted for changes in already approved products such as technology changes or the addition of a new indication.  It is essential that FDA complete the review process for these products quickly and thoroughly.  Due to the renegotiation of MDUFMA, the Performance targets for 180 day PMA Supplements will be to arrive at a decision on 85% of applications within 180 days and 95% within 210 days. 

 

Performance:  CDRH is currently exceeding performance for the FY 2009 target by making decisions on 93% of 153 PMA Supplements applications in 180 days and 97% of 153 PMA Supplements applications in 210 days. The cohort remains open.  The FY 2010 performance data for this goal will not be available until January 2012. If the number of reviewers remains constant, CDRH expects performance levels to decrease due to the increasing complexity of PMAs.

 

3.      Percentage of 510(k)s (Premarket Notifications) reviewed and decided upon within 90 and 150 days. (253205)

 

Context:  Complete decision constitutes the comprehensive review of the application package initially received by FDA and FDA’s decision letter.  A decision will result in one of the following designations for each application: substantially equivalent or not substantially equivalent.  This goal for review and decision on 510(k)s within 90 days addresses the statutory requirement to review a 510(k) within 90 days.  Due to the renegotiation of MDUFMA, the Performance targets for 510(k)s will be to arrive at a decision on 90% of applications within 90 days and 98% within 150 days. 

 

Performance:  CDRH is currently exceeding performance for tier 1 of this FY 2009 target by making decisions on 91% of 3,324 510(k)s in 90 days and met performance for tier 2 of the FY 2009 target by making decisions on 98% of 3,324 510(k)s in 150 days. The cohort remains open.  The FY 2010 performance data for this goal will not be available until January 2012.  If the number of reviewers remains constant, CDRH expects performance levels to decrease.

 

4.      Number of Medical Device Bioresearch Monitoring (BIMO) inspections. (253201)

 

Context:  FDA’s mission includes assuring the protection of human research subjects, the quality and integrity of research, and the advancement of new medical technologies.  A FDA-regulated research community that consists of Clinical Investigators, Sponsors and Monitors, and Institutional Review Boards has a shared responsibility to oversee this research in a truthful and ethical manner.  For FY 2012, this performance goal continues to reflect the FY 2007 change in the selection of firms for inspection to a more risk based approach.  There are no projected changes to this goal in FY 2012. In FY 2012, the target is maintained at the FY 2011 level.

 

Performance: In FY 2010, FDA exceeded this goal of 300 by conducting 392 medical device related Bioresearch Monitoring inspections.  Reason why this goal was exceeded: Bioresearch Monitoring Inspections are conducting based on the submission of PMA applications to FDA each year.  There will be no change to the goal in year to come because the increase in FY 2010 was an anomaly rather than a trend of what is to come.  Historically, Bioresearch Monitoring inspections as a result of PMA applications align with the target of 300. 

5.      The minimum number of reports per year that 80 percent of MedSun hospitals, enrolled for at least 11 months in the program will submit.  (252201)

 

Context:  FDAMA gives FDA the mandate to replace universal user facility reporting with the Medical Product Surveillance Network (MedSun) that is composed of a network of user facilities that constitute a representative profile of user reports.  MedSun is a critical component in increasing the percent of the population covered by active surveillance, which will allow for more rapid identification and analysis of adverse events.

 

Performance: For FY 2010, the target for minimum number of reports per year was 3.  This target was reached. CDRH will keep the target for minimum number of reports at 3 for FY 2011 and FY 2012.

 

6.      By 2013, enroll 80% of the top 15 MDR reporters by volume in the voluntary eMDR (Medical Device Reporting) program. (252202)

 

Context:  Improving electronic reporting of adverse events will help the FDA maintain its safety surveillance of FDA-regulated products.  Information obtained from these reports may prompt a modification in use or design of the product, improves the safety profile of devices, and leads to increased patient safety.  eMDR allows FDA to receive medical device adverse event reports electronically.  eMDR will improve the agency’s ability to detect important postmarket medical device issues and will reduce the reporting burden for both large and small volume medical device adverse event reporters.

 

Performance:  In FY 2010, CDRH enrolled 47% of the top 15 MDR reporters into the eMDR program, exceeding the target of 40%.  CDRH is on track to meet the FY 2011 goal of enrolling at least 67% of the top 15 MDR reporters.

 

7.      Increase percentage of time CDRH meets the targeted deadline of 45 working days to review GMP information and issue Device Warning Letters.  (254202)   

 

Context:  FDA's practice is to give industry an opportunity to take voluntary prompt action to correct violations.  A Warning Letter is issued for violations of significant regulatory significance which may lead to enforcement actions if not promptly and adequately corrected.  FDA inspectors issue Establishment Inspection Reports and other documents explaining the nature of observed violations.  Timely Compliance Officer review is a key element in issuing Warning Letters in a timely manner.   

 

Performance: CDRH did not expect to meet the 90% target in FY 2010 due to the lag time it takes for new hires to be able to reach a level of proficiency that will allow the staff to operate at optimal performance. In FY 2010, CDRH was able to meet the 45 working day target for device warning letters 66% of the time. Based on the current staff, the targets for FY 2011 and FY 2012 have been revised and set at 75%.

 

8.      Number of domestic and foreign Class II and Class III device inspections. (254201) 

 

Context:  The ultimate goal of preventing unsafe and ineffective devices from reaching the consumer will be advanced by detecting and intercepting unsafe and ineffective product at the manufacturing level.  By utilizing risk-based inspection strategies and focusing on surveillance throughout a products life-cycle FDA will be better able to protect the public health by ensuring both the quality and effectiveness of medical devices available in the U.S. marketplace.  For FY 2010, the target was increased to 1,365 to reflect the FY 2009 Appropriations.  In FY 2011, the target is being increased by 80 inspections for a new target of 1,445 inspections.  In FY 2012, the target is being increased by 70 inspections for a new target of 1,515 inspections.

 

Performance:  FDA exceeded the FY 2010 medical device performance goal of 1,365 by inspecting 1,659 foreign and domestic high-risk Class II and Class III medical device manufacturers.  

 

9.  Percentage of an estimated 8,700 domestic mammography facilities that meet inspection standards, with less than 3% with Level I (serious) problems. (254101)

 

Context:  This goal will ensure that mammography facilities remain in compliance with established quality standards and improve the quality of mammography in the United States.  Under the Mammography Quality Standards Act (MQSA), which was reauthorized in 2004, annual MQSA inspections are performed by trained inspectors with FDA, with State agencies under contract to FDA, and with States that are certifying agencies.  State inspectors conduct approximately 90% of inspections.  Inspectors perform science-based inspections to determine the radiation dose, to assess phantom image quality, and to empirically evaluate the quality of the facility's film processing.  MQSA requires FDA to collect fees from facilities to cover the cost of their annual facility inspections.  FDA also employs an extensive outreach program to inform mammography facilities and the public about MQSA requirements.  These include: an Internet website, collaboration with NIH to provide a list of MQSA-certified facilities, and a toll-free facility hot line. 

 

Performance:  FDA met this goal in FY 2010 by ensuring that 97% of an estimated 8,700 mammography facilities met inspection standards with less than 3% level I (serious) problems.  Inspection data continue to show facilities' compliance with the national standards for the quality of mammography images.  Improving the quality of images should lead to more accurate interpretation by physicians and, therefore, to improved early detection of breast cancer.

 

10.  Number of technical analyses of postmarket device problems and performance.  (252101)

 

Context:  Postmarket device problems and performance issues constitute one of the Center's primary public health priorities.  Typically, the appearance of such problems begins with many ambiguities and gaps in understanding exactly what happened in the reported incident(s) and, more importantly, why.  The Center's technical analysis of these problems illuminates each of these two questions, and points the way to an optimal science-based regulatory response involving the Center as a whole.

 

Performance:  In FY 2010, CDRH completed 127 technical analyses of device problems. This baseline encompasses work by CDRH laboratory staff on Health Hazard Evaluations, PMI Action Teams, formal enforcement cases, Postmarket Surveillance Studies, development of inspectional guidances, field inspections, and regulatory sample analyses.  The reports for which involve laboratory staff activities are typically selected because of the unusually difficult engineering questions that are posed.  The technical analyses provided by CDRH’s laboratory staff are used to assess the priority and hazards, determine the adequacy of proposed corrective actions, determine appropriate test methods, and develop case strategies for reported problems. 

 

11.  Number of technical reviews of new applications and data supporting requests for premarket approvals.   (253207)

 

Context:  The most challenging premarket device regulatory issues faced by CDRH typically involve (1) novel technologies in which the relevant technical questions are not obvious; (2) submissions in which there is a need for independent data to verify manufacturers' claims; or (3) new products for which there are no well validated test methods.  Technical reviews by CDRH engineers and scientists bring specialized expertise to the process, frequently enabling the Center to address these challenges in a science-based decision process.

 

Performance:  In FY 2010, CDRH completed 1,429 technical reviews of new applications. The number or technical reviews of new applications and data supporting requests for premarket approvals was greater than expected for FY 2010 due to an influx of applications for MRI compatible medical devices. It is anticipated that the number of technical reviews will return to the baseline in FY 2011. These reviews by CDRH’s laboratory staff are associated with the submissions having the most novel, difficult, and complex engineering analyses and issues. 


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