What does PMAA mean in FDA
PMAA stands for Pre-Market Approval Application. This application needs to be filled out by anyone wanting to market a medical device in the United States. It is submitted to the Food and Drug Administration (FDA) and must prove that the device is safe and effective.
PMAA meaning in FDA in Governmental
PMAA mostly used in an acronym FDA in Category Governmental that means Pre-Market Approval Application
Shorthand: PMAA,
Full Form: Pre-Market Approval Application
For more information of "Pre-Market Approval Application", see the section below.
» Governmental » FDA
Essential Questions and Answers on Pre-Market Approval Application in "GOVERNMENTAL»FDA"
What does PMAA stand for?
PMAA stands for Pre-Market Approval Application.
Who submits a PMAA?
A PMAA is submitted to the FDA by individuals or companies wanting to market a medical device in the United States.
What information does a PMAA include?
A PMAA includes safety, effectiveness, clinical studies, manufacturing information, labeling, and postmarketing surveillance plans about the device being marketed.
How long does it take for a PMAA to be approved?
The timeline of approval depends on how quickly sufficient information can be gathered and provided to the FDA. Typically approvals can range from several weeks to several months or even years depending on what type of device is being marketed.
Final Words:
In conclusion, any product being marketed in the United States as a medical device must have its Pre-Market Approval Application approved before being brought onto the market. This application should include safety/effectiveness clinical studies, manufacturing information as well as labeling and postmarketing surveillance plans about the product/device being marketed. There may also be added costs associated with this process dependent upon any additional research/data analysis that may need to be conducted.
PMAA also stands for: |
|
| All stands for PMAA |