US FDA Regulatory Consulting Services

Practical RA provides regulatory consulting services for medical devices and IVDs seeking clearance or approval from the US Food and Drug Administration (FDA). Our support spans early regulatory strategy through pre-submission engagement, submission preparation, and ongoing compliance.

We work with manufacturers of all sizes who require practical, compliant pathways for US market access, tailored to device classification and intended use.

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How We Support

510(k) Submissions

Compilation and support of 510(k) submissions to demonstrate substantial equivalence for FDA clearance.

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513(g) Requests

Preparation of 513(g) submissions to obtain FDA feedback on device classification and regulatory requirements.

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Pre-Submissions (Q-Sub)

Strategic planning and preparation of FDA pre-submission packages to clarify regulatory expectations.

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Regulatory Strategy

Regulatory pathway planning and strategy development to support efficient US market access.

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Frequently Asked Questions

Questions we commonly receive from device manufacturers tackling US market access challenges:

Yes. We assist with device classification and pathway selection, including 510(k), De Novo, PMA, and 513(g), based on device risk, intended use, and available predicates.

Yes. We provide hands-on support for the preparation, review, and compilation of FDA submissions, including 510(k) and pre-submission packages.

Yes. We support the planning and preparation of pre-submission (Q-Sub) requests, including drafting questions, briefing materials, and reviewing FDA feedback.

Certainly. While we cannot (yet) act as your US Agent, we can assist you in creating and onboarding the various online accounts needed to manage your US device registration and listing. This can includes your FURLS and User Fee accounts, as well as obtaining the DUNS number needed to register your facility.

Ensure your compliance with the expertise of Practical RA

Talk to our team of experts to see how we can launch your business in the US today.

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