Submission of Clinical Research Data to FDA to Support Product Marketing Applications

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Type Standard Implementation/Specification Standards Process Maturity Implementation Maturity Adoption Level Federally required Cost Test Tool Availability
Standard
Final
Production
Rating 5
Yes
Free
Yes
Standard
Final
Production
Rating 3
Yes
Free
N/A
Standard
Final
Production
Rating 5
No
Free
Yes
Standard
Final
Production
Rating 1
No
Free
N/A
Standard
Final
Production
Rating 5
Yes
Free
N/A
Standard
Final
Production
Rating 3
Yes
Free
N/A
Implementation Specification
Final
Production
Rating 1
No
Free
N/A
Standard
Final
Production
Rating 1
Yes
Free
N/A
Standard
Final
Feedback requested
Feedback Requested
No
Free
No
Emerging Implementation Specification
Balloted Draft
Feedback requested
Feedback Requested
No
Free
No
Limitations, Dependencies, and Preconditions for Consideration Applicable Security Patterns for Consideration
  • Feedback Requested