All the foreign medical device companies who are required to comply with FDA registration requirements should appoint U.S Agent for communication with FDA. US Agent acts acts as medium of communication between FDA and foreign company.
Pragmatic offer services to act US Agent for Medical Device companies.
Responsibilities of US Agent for Medical Device companies.
The responsibilities of the U.S. agent are limited and include:
Pragmatic Compaliance offer U.S Agent services to foreign companies at competitive fees. Our fee for U.S Agent services is $ 299 for 12 months.
We do not hike prices during annual renewal or charge any other hidden fees. All prices are upfront. We confirm FDA US Agent notifications immediately.
Along with U.S Agent services , we also offer medical device registration and listing services.
Complete our online U.S Agent form to sign U.S Agent contract.BACK