Our 510(k) services

Clients hire us mainly to clear medical devices through FDA’s 510(k) program. This often leads to help with related issues, such as registering with FDA and importing devices into the country. We generally provide such extras at no charge.

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    FDA registration Establishment registration and device listing

    Medical device manufacturers and importers must register with FDA and pay an annual licensing fee. In addition, they must list all medical devices to be marketed in the United States. We handle this service at no charge after clearing your 510(k).

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    Import and Export activities Getting devices into the country… or out

    The U.S. allows you to import medical devices duty free. That’s the good news. But if shipments are not labeled properly, customs agents impound the goods and cause insufferable delays. In addition, FDA recently implemented a new system for radiation-generating devices, which must carry unique “accession” numbers. We help clients overcome these import hurdles. We further help you obtain Certificates to Foreign Governments (CFGs) when exporting to markets that rely on FDA “approval” for regulatory responsibility.

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    Universal Device Identifier Compliance with new UDI regulations

    FDA’s new Universal Device Identifier system began phasing in during 2014. Class 2 devices, which generally include those under the 510(k) umbrella, face a significant labeling and reporting deadline in September 2016. We offer free guidance on this significant new regulatory burden on medical device manufacturers and importers.

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    Other medical device regulations Small business designation; U.S. agent

    The first step with a new engagement is to file for Small Business Designation (SBD), which takes about 45 days. This saves the client $7,924 (75% of FDA’s review fee).

    Foreign companies must name a domestic person or corporation its US Agent for notices from the agency. We often serve this function for foreign clients.