Performance Improvement 2008. How do Medical Device Companies View the Food and Drug Administration's Pre-Market Review Process?

01/01/2008

The purpose of the 2007 FDA Center for Devices and Radiological Health Premarket Industry Perception Survey was to obtain industry feedback on the premarket review process to help determine how customers perceive the medical device review process, identify areas that are working well, and to identify areas that may need improvement. A random sample of industry contacts was selected from final Premarket application decisions for the twelve month period April, 2006 through March, 2007. There were 354 responses received: 224 for the Office of Device Evaluation (ODE) and 130 for the Office of In Vitro Diagnostics (OIVD).

When comparing the survey results from 2006 with survey results from 2007, some of the respondent perceptions remain unchanged. Approximately 90 percent of survey respondents agreed that ODE and OIVD reviewed and processed Premarket submissions in a timely manner in both years. Ninety percent of respondents agreed that OIVD´s staff exhibited an appropriate level of scientific expertise in reviewing the submissions. The number of survey respondents who agreed that ODE´s staff exhibited an appropriate level of scientific expertise in reviewing the submissions increased from 80 percent in 2006 to 87 percent in 2007. The perception that the Center for Devices and Radiological Health Premarket review meetings were productive and met respondents´ needs improved significantly. Satisfaction with ODE staff increased, from 30 to 49 percent. Satisfaction with OIVD increased from 42 to 56 percent. One broad implication was that new and updated guidance documents are needed (they lag advancements in technology). Other broad implications regarding the Centers for Devices and Radiological Health are that it: be less burdensome, treat the medical device industry fairly, courteously, and professionally, address review inconsistencies between branches and reviewers, and provide quicker feedback to resolve issues submissions.

Report Title: 2007 Premarket Industry Perception Survey, Office of Device Evaluation (ODE and Office of Invitro Diagnostics (OIVD). Report may be obtained from Federal Contact
Agency Sponsor: FDA, Food and Drug Administration
Federal Contact: Bonnie Markovitz, 240-276-8924
Performer: Office of Device Evaluation and Office of Invitro Diagnostics
PIC ID: 8762

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