FDA Consulting for
Medical Device Manufacturers
BioVision provides complete FDA consulting and submission services that help medical device manufacturers clear the U.S. market efficiently.
We prepare and manage 510(k), De Novo, and PMA submissions,
navigate the FDA's Q-Submission program,
and ensure your quality system meets the requirements of
the new Quality Management System Regulation (QMSR).
Which FDA pathway does your device need?
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510(k) (Premarket Notification) — for devices substantially equivalent to a legally marketed predicate. The most common pathway for Class II devices.
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De Novo — for novel low-to-moderate-risk devices with no suitable predicate.
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PMA (Premarket Approval) — the most rigorous pathway, required for high-risk Class III devices.
The right pathway depends on your device's classification and risk:
QMSR: the new FDA quality requirement
As of February 2026, the FDA's Quality System Regulation (21 CFR Part 820) has been replaced by the Quality Management System Regulation (QMSR), which incorporates ISO 13485. Manufacturers selling in both the U.S. and EU can now align their quality systems more closely. BioVision helps you transition smoothly to QMSR and maintain a single, harmonized quality system.
How BioVision supports your FDA submission:
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Device classification and pathway determination.
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Predicate identification and substantial equivalence strategy.
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Pre-Submission (Q-Sub) meetings with the FDA.
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Full preparation of the 510(k), De Novo, or PMA submission.
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Response management for FDA Additional Information requests.
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QMSR-compliant quality system implementation.
Frequently Asked Questions
How long does a 510(k) take?
FDA review of a traditional 510(k) typically takes around 90 days of review time, though total time to clearance depends on submission quality and any information requests. Strong preparation is the single biggest factor in avoiding delays.
What is the difference between 510(k) clearance and PMA approval?
A 510(k) results in “clearance” based on substantial equivalence to an existing device. A PMA results in “approval” based on independent evidence of safety and effectiveness, and is reserved for high-risk devices.
Do I need a U.S. Agent?
Foreign manufacturers without a U.S. presence must designate a U.S. Agent for FDA communications. BioVision can advise on this requirement as part of your market-entry plan.