Entering the US
Entering the US: FDA alongside MDR, without writing the documentation twice
Entering the US means meeting FDA requirements, from the Quality Management System Regulation in 21 CFR 820 to a 510(k), De Novo or PMA submission, alongside the MDR documentation you already maintain. Nitro cOS keeps both sets of requirements in one dependency map, so one document can satisfy both markets without being written twice.
What the regulation requires
FDA regulates medical devices under Title 21 of the Code of Federal Regulations. Device classification decides the premarket route: most Class II devices clear through a 510(k) by showing substantial equivalence to a predicate, novel low-to-moderate-risk devices go through De Novo, and Class III devices need a Premarket Approval backed by clinical evidence.
The Quality Management System Regulation (21 CFR Part 820) incorporates ISO 13485:2016 by reference, which brings FDA and EU quality system expectations closer together. Electronic records and signatures fall under 21 CFR Part 11, and cyber devices carry cybersecurity requirements under section 524B of the FD&C Act.
Much of the evidence overlaps with MDR: risk management, design controls, verification and validation, usability and software lifecycle documentation. The structure, terminology and submission formats differ, which is where duplicated work usually creeps in.
How Nitro helps
Nitro cOS maps FDA and MDR requirements against the same set of documents. When an engineer asks what a change requires, the answer covers both the EU technical file and the US submission, with references to the regulation on each side.
Drafts are produced from your existing MDR documentation, so a design verification report or risk analysis written for CE marking becomes the starting point for its FDA counterpart rather than a blank page. Citations show where every statement came from.
The dependency map shows which documents serve both markets and which are market-specific. That is the input your regulatory team needs to plan a submission and to keep both files consistent afterwards.
Questions
- Can one document satisfy both FDA and MDR?
- Often, yes, when it is structured to meet both. Nitro shows where the requirements overlap and where they differ, so your team decides deliberately which documents to share and which to keep market-specific.
- Does Nitro prepare the 510(k) or PMA submission?
- Nitro drafts the underlying documentation from your own material and maps what the submission needs. Assembling and filing the submission, and the regulatory strategy behind it, stay with your team or consultant.
- Does Nitro support 21 CFR Part 11?
- Nitro is designed to support Part 11: audit trails, controlled access and electronic signatures bound to a named reviewer on every approval.