Survey Objectives

Contribute to current reform debate by conducting a large-scale online survey that focuses on:
- Timelines
- Interactions with the agency
- Challenges in current implementation and specific opportunities for improvement of the process
- Data collection to elucidate aspects of the process that are often misunderstood or where misperception exists
- Comparative experience with international regulatory programs

Requirements for Participation

- Respondents need to have been involved with a 510(k) submission over the course of the past 3 years
- Participation anonymous
- Time requirement: 45–60 minutes (can pause and resume)
- Need to complete survey by January 31, 2011

Organization of the survey

The survey consists of the following five sections:

1) Demographic information (9 questions)

 2) Predictability (13 questions)

3) Interaction with FDA (15 questions)

4) Process (15 questions)

5)  Device-specific experience (34 questions) 

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