FDA-TRACK CDRH Premarket Dashboard

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Contents:

• Key Center Director Measures
• Program Measures
• Key Projects

Note: Information is as of January 31, 2012.  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.

Key Center Director Measures

I. Training Measures

A. Ensure that essential and comprehensive training, education and professional development are provided to employees as required by Section 742 of the Food, Drug and Cosmetic Act. 

1. Total number of training events in the month
2. Total number of Office of Device Evaluation (ODE) employees who completed training events in the month
3. Total number of Office of In Vitro Diagnostic Device Evaluation & Safety (OIVD) employees who completed training events in the month 

II. Integration Measures

A. Increase the percent of intra- and inter-office eConsults completed on time.  eConsults are used to facilitate the exchange of scientific information and staff expertise across CDRH, therefore promoting collaborative efforts within the Center.  Consultations are completed for a variety of work products requiring expertise across CDRH offices, including premarket device submissions, post-approval studies, and compliance and enforcement actions.

1. Percent of ODE intra- and inter-Office eConsults completed on time during the month
2. Percent of OIVD intra- and inter-Office eConsults completed on time during the month

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Program Measures

I. Premarket Notification (510(k)) Review Measures

A. Increase public access to medical devices by meeting the Medical Devices User Fee Amendments (MDUFA II) 510(k) premarket review decision goals.

1. Percent of CDRH (ODE & OIVD) 510(k) decisions meeting MDUFA goals during the month
2. Percent of CDRH ODE 510(k) decisions meeting MDUFA goals during the month
3. Percent of CDRH OIVD 510(k) decisions meeting MDUFA goals during the month

II. 180-Day Premarket Approval (PMA) Supplement Review Measures

A. Timely review changes that affect the safety or effectiveness of medical devices that require FDA premarket approval of a 180-Day PMA Supplement.

1. Percent of CDRH (ODE & OIVD) 180-Day PMA Supplements decisions made in 180 days or less during the quarter
2. Percent of ODE 180-Day PMA Supplements decisions made in 180 days or less during the quarter
3. Percent of OIVD 180-Day PMA Supplements decisions made in 180 days or less during the quarter

III. Improve Transparency of Premarket Decisions

Office of Device Evaluation

A. Provide access to approved 180-day PMA supplement review memos from 2 ODE branches (Pacing and Defibrillator and Leads Branch & Plastic Devices Branch).

1. Percent of 180-day PMA supplement summary review memos posted on the web within 60 days from approval to posting during the month

Office of In Vitro Diagnostic Evaluation and Safety

B. Increase public access to medical device information by posting 510(k) in-vitro diagnostic (IVD) decision summaries.

1. Percent of 510(k) IVD decision summaries posted on the web within the 45 day timeframe during the month

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Key Projects

Office of Device Evaluation

I. Improve 510(k) Submission Quality 

Office of In Vitro Diagnostic Evaluation and Safety

II. Personalized Medicine

 
 

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