FWIW I can provide the FDA protocol for review and
Post# of 468
(Total Views: 92)
Posted On: 09/04/2024 3:30:42 PM
FWIW I can provide the FDA protocol for review and approval of PMA applications........Completed are highlighted IMO! 60-80% complete
The FDA’s Premarket Approval (PMA) process is a rigorous pathway for medical devices to ensure their safety and effectiveness before they can be marketed in the United States. Here’s a breakdown of the key steps involved:
Pre-Submission: Manufacturers often engage with the FDA early to discuss their plans and get feedback on their clinical study designs.
Application Submission: The manufacturer submits a detailed PMA application, including clinical data, technical specifications, and manufacturing information.
Administrative Review: The FDA conducts an initial review to ensure the application is complete.
Scientific Review: A thorough evaluation of the clinical data and other information is conducted by FDA scientists and engineers.
Advisory Committee Meeting: Sometimes, the FDA convenes an advisory committee of external experts to review the application and provide recommendations.?????
Inspection: The FDA may inspect the manufacturing facilities to ensure compliance with regulatory standards.
Decision: The FDA makes a decision to approve, deny, or request additional information. If approved, the device can be marketed in the U.S.
The FDA’s Premarket Approval (PMA) process is a rigorous pathway for medical devices to ensure their safety and effectiveness before they can be marketed in the United States. Here’s a breakdown of the key steps involved:
Pre-Submission: Manufacturers often engage with the FDA early to discuss their plans and get feedback on their clinical study designs.
Application Submission: The manufacturer submits a detailed PMA application, including clinical data, technical specifications, and manufacturing information.
Administrative Review: The FDA conducts an initial review to ensure the application is complete.
Scientific Review: A thorough evaluation of the clinical data and other information is conducted by FDA scientists and engineers.
Advisory Committee Meeting: Sometimes, the FDA convenes an advisory committee of external experts to review the application and provide recommendations.?????
Inspection: The FDA may inspect the manufacturing facilities to ensure compliance with regulatory standards.
Decision: The FDA makes a decision to approve, deny, or request additional information. If approved, the device can be marketed in the U.S.
(0)
(0)United Ecoenergy Corp. (UEEC) Stock Research Links
Scroll down for more posts ▼