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PaxMed International
Leaders in Regulatory Affairs for the Medical Device Industry
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FDA Halts Medical Device Submissions and Fee Payments

October 6, 2025 PaxMed International

As of October 1, 2025, the U.S. Food and Drug Administration (FDA) has announced that it is not accepting new…

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Posted in: News

FDA 2026 MDUFA User Fees

October 1, 2025 PaxMed International

User Fees for FY 2026 October 1, 2025, through September 30, 2026. Annual Establishment Registration Fee: $11,423 Most establishments must…

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Posted in: News Filed under: 510(k) fee, Establishment Registration Fee, FDA User Fees, Small Business fee, Standard Fee

Academy of Osseointegration Annual Meeting

March 25, 2025 PaxMed International

Floyd Larson, PaxMed’s president, will be attending the Academy of Osseointegration 40th Annual Meeting in Seattle, Washington March 27 through…

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Posted in: News

FDA 2025 MDUFA User Fees

October 1, 2024 PaxMed International

User Fees for FY 2025 Annual Establishment Registration Fee: $9,280 All establishments must pay the establishment registration fee. There are no waivers…

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Posted in: News Filed under: 510(k) fee, FDA User Fees, MDFUA, MDUFA User Fees, Medical Device, Medical Device FDA Fee

Regulatory Specialist

February 15, 2024 PaxMed International

The Regulatory Specialist will be a key member of the PaxMed International team, responsible for supporting the development of regulatory…

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Posted in: Career Opportunities

100th FDA 510(k) Clearance by PaxMed’s Dr. Kevin A. Thomas

August 30, 2023 PaxMed International

PaxMed International assists our clients with U.S. Food and Drug Administration (FDA) and other regulatory approvals, including 510(k) submissions for…

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Posted in: News

FDA 2024 MDUFA User Fees

August 9, 2023 PaxMed International

User Fees for FY 2024 Annual Establishment Registration Fee: $7,653 All establishments must pay the establishment registration fee. There are no waivers…

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Posted in: News Filed under: 510(k) fee, FDA User Fees, MDFUA, MDUFA User Fees, Medical Device, Medical Device FDA Fee

FDA 2023 MDUFA User Fees

October 7, 2022 PaxMed International

User Fees for FY2023 Annual Establishment Registration Fee:  $6,493 Below are the Fees for Fiscal year 2023 (October 1, 2022…

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Posted in: News Filed under: 510(k) fee, FDA User Fees, MDFUA, MDUFA User Fees, Medical Device, Medical Device FDA Fee

PaxMed Celebrates the 250th FDA 510(k) Clearance

October 20, 2021 PaxMed International

PaxMed International’s 30th Anniversary in the regulatory space was celebrated in 2020 as a leader in assisting companies domestically and…

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Posted in: News

FDA 2022 MDUFA User Fees

August 24, 2021 PaxMed International

User Fees for FY2022 Annual Establishment Registration Fee:  $5,672 Below are the Fees for Fiscal year 2022 (October 1, 2021…

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Posted in: News Filed under: 510(k) fee, FDA User Fees, MDFUA, MDUFA User Fees, Medical Device, Medical Device FDA Fee

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PaxMed International, LLC
1925 Palomar Oaks Way, Suite 210
Carlsbad, CA 92008 USA

United States, toll-free: (877) 792-1235
International Telephone: +1 (858) 792-1235
Fax: +1 (858) 792-1236

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