US Agent for Medical Device companies.
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:
- assisting FDA to communicate with the foreign establishment,
- responding to questions related to foreign establishment’s devices that are imported or offered for import into the United States,
- assisting FDA for foreign establishment inspection scheduling
- incase, FDA is unable to contact the foreign manufacturer , FDA may contact U.S Agent for regulatory communication purpose.
- Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).
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.