US Agent Services (FDA Official Correspondent)

One of the Food Drug Administration’s (FDA) requirements is that all Medical Device and In Vitro Diagnostics companies without a presence in the United States (US) must appoint a registered US Agent. This person must be a resident of the United States or maintain a physical place of business in the US, also the FDA US Agent must be available to answer the phone or have an employee available to answer the phone during normal business hours, which makes RQMIS a perfect fit and a perfect solution for you.

As an FDA US Agent (FDA Official Correspondent), RQMIS can assist with your FDA registration. Establishment registration utilizing the FDA Unified Registration and Listing System (FURLS) is the first step in reaching US markets with your medical device. Every year FDA updates the registration costs.

Registration requirement applies to the following categories of foreign establishments:

  • Primary Manufacturers
  • Contract Manufacturers and Remanufacturers
  • Contract Sterilizers
  • Foreign Exporter of medical devices located in a non-US country
  • Specification Developers/Reprocessors of single use medical devices

As your US Agent, RQMIS will:

  • Assist FDA in communications with your non-US establishment
  • Respond to questions concerning your non-US establishment’s devices that are imported or offered for import into the US
  • Assist FDA in scheduling inspections of your non-US establishment
  • Assist with FDA inspections
  • Receive information or documents from the FDA on behalf of your non-US establishment in the absence of effective communication between the two entities

As your Official Correspondent, RQMIS will:

  • Handle annual registration and listing, and check FDA Registration fees/cost
  • Creating new registrations and listings
  • Canceling obsolete registrations and listings
  • Changing/updating registration and listing information and check FDA Registration fees/cost
  • Maintain and a current list of officers and directors and submit it to the FDA upon request
  • Receive pertinent correspondence from the FDA on your behalf.
  • Report adverse events (under 21CFR803 Medical Device Reporting (MDR) regulations)

FDA Medical Device User Fee Rates for Fiscal Year 2022

Federal law authorizes the U.S. Food and Drug Administration (FDA) to collect user fees / cost for certain medical device submissions and establishment registration. On August 2, 2021, the FDA announced the FY2022 user fees / prices for FDA Medical Device User Fees for 2022 in Medical Device User Fee Rates for Fiscal Year 2022. User fees are required for the following types of medical device submissions:

  • FDA premarket notifications (510(k)s)
  • FDA premarket approval applications (PMAs)
  • product development protocols (PDPs)
  • FDA De Novo classification requests
  • some PMA and PDP supplements (for example, panel-track, 180-day, real-time, 30-day notice)
  • premarket reports (PMRs)
  • annual fee for periodic reporting on a class III medical device (PMAs, PDPs, and PMRs)
  • requests for medical device classification information (513(g)s)
  • original biologics license applications (BLAs) for certain medical devices reviewed by the FDA's Center for Biologics Evaluation and Research (CBER)
  • BLA efficacy supplements

In addition, all medical device establishments are required to pay an annual establishment registration fee. Below is the price listed.

FY2022 User Fee for Establishment Registration

For FY2022, the registration fee / cost for each establishment registration is $5,672 (in United States dollars). There are no waivers or reductions for small establishments, businesses, or groups registration on the fees.

The annual establishment registration fee must be paid between October 1, 2021, and December 31, 2021.

FY2022 User Fees for Medical Device Submissions

The following table identifies the FY2022 User Fees for Medical Device Submissions (in U.S. dollars).

Application TypeStandard FeeSmall Business Fee
De Novo Classification Request$112,457$28,114
Panel-track Supplement$281,143$70,286
180-Day Supplement$56,229$14,057
Real-Time Supplement$26,240$6,560
BLA Efficacy Supplement$374,858$93,714
30-Day Notice$5,998$2,999
Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs)$13,120$3,280

For further information regarding to the Registration cost Contact RQMIS team

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