Medical
FDA Medical Device Development Process
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FDA Medical Device Development Process

1
Identify needs and develop initial concept for medical device
2
Conduct a risk assessment
3
Develop a design and development plan
4
Create device design inputs
5
Approval: Device Design Inputs
6
Develop the prototype
7
Conduct preclinical testing
8
Conduct software verification, validation and risk analysis
9
Prepare and submit Investigational Device Exemption (IDE) Application
10
Approval: IDE Application Submission
11
Conduct a clinical trial
12
Evaluate clinical trial results
13
Prepare and submit a Pre-Market Approval application
14
Approval: Submission of Pre-Market Approval
15
Respond to FDA queries and objections
16
Approval: Final Product Design and Claims
17
Production of the approved device
18
Implement post-market surveillance measures