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FDAbasics

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FDAbasics has helped foreign and domestic medical device companies navigate US FDA requirements since 1995. Based in Brooklyn, New York, we serve manufacturers, importers, and distributors in more than 100 countries, providing the regulatory infrastructure that keeps devices in good standing with the FDA year after year.

Our medical device services include:
-US Agent Representation for foreign establishments, including dedicated agent services for 510(k), PMA, De Novo, HDE, and IDE submissions
-Establishment Registration (initial and annual renewal) for domestic and foreign facilities
-Device Listing submissions, including listings for multiple devices under a single registration
-GUDID / UDI account setup and device identifier submissions
-Medical Device Label Review for FDA compliance
-Small Business Determination (SBD) Waiver guidance for qualifying manufacturers
-Proactive Annual Renewal Management so the MDUFA payment window is never missed

Medical device companies choose FDABasics for our plain-spoken guidance, fast turnaround (registration and listing typically completed in four business days), and 30+ years of hands-on experience with FURLS, GUDID, and the full medical device regulatory lifecycle. We are 5-star rated on Trustpilot and Google. Contact us to discuss your registration and compliance needs.

Company Details

Address
1 Prospect Park W Ste 4D
BROOKLYN, NY 11215

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Categories

Regulatory & Quality Control > Regulatory Compliance Consultants
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