Services to Ease FDA Regulatory Compliance

US Agent for Medical Device Companies




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.

Complete our online U.S Agent form to sign U.S Agent contract.

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