Ada, Michigan, United States

Medical Device Establishments

  • Assistance with FDA Registration + “U.S. Agent” appointment $695 per calendar year

  • Device Listing $95 / Device

  • Label Review $995 / Device

*** With the passage of the Medical Device User Fee Amendments of 2012 (MDUFA III), all medical device establishments must pay the FDA registration fee, regardless of establishment type or activities conducted. The FDA annual registration fees for FY 2015 is $3,646. This registration fee will be added to the above described service fees, and must be paid in advance of our services being provided.

  • For issuance of a “Good Standing Certificate”, the fee is $195.

Inquire at about DISCOUNTS for multiple-facility, multi-label or multi-year arrangements.

We maintain legal and regulatory consultants on staff to provide our clients with critical information and updates on FDA activity, the Food Safety Modernization Act, and other relevant U.S. FDA regulations. If you are interested in obtaining consulting on regulatory issues, please contact us to discuss our hourly consulting rates (which range between $180 – $225).

All registration and payment information shall be kept strictly confidential (except to the extent such information is required to be disclosed to the FDA or other government authorities) and will not be sold to any third parties under any circumstances. All fees are stated in U.S. dollars, and may be paid via international wire transfer to our bank account at JPMorgan Chase or payment by credit card via a Paypal invoice. No refunds.

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