NDA vs PMA

Hi I would like to know the details of the PMA as well as what NDA is and what are the differences between the two?

[Shaleen]

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the demonstration) built up three administrative classes for therapeutic gadgets.

The three classes depend on the level of control important to guarantee that the different sorts of gadgets are protected and compelling.

The corrections characterize a Class III gadget as one that backings or manages human life or is of considerable significance in avoiding debilitation of human wellbeing or introduces a potential, nonsensical danger of ailment or harm .

Pre market endorsement by FDA is the required procedure of exploratory survey to guarantee the security and adequacy of Class III gadgets.

An affirmed Pre market Approval Application (PMA) - like an endorsed New Drug Application (NDA) - is, in actuality, a private permit allowed to the candidate for advertising a specific restorative gadget.

A Class III gadget that neglects to meet PMA necessities is thought to be debased under Section 501(f) of the demonstration and can't be promoted.

The basic difference between PMA and NDA is that PMA is to be gained for medical device or even a drug to be sold in the market. As of NDA is for getting permission for manufacturing any new drug under the regulation laid down by FDA.

Address:

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)