US FDA Regulatory Strategy and Planning
Practical RA provides regulatory strategy support for manufacturers planning entry into the United States market, helping define appropriate FDA pathways and evidence requirements.
Why FDA Regulatory Strategy Matters
US FDA regulatory compliance is shaped by a combination of legislation, guidance documents, recognised standards, and evolving Agency expectations. While submission types such as 510(k), De Novo, PMA, and 513(g) are well defined, selecting the appropriate pathway and sequencing regulatory activities requires careful planning. Early strategic decisions influence evidence generation, timelines, and overall regulatory risk.
A common issue encountered by manufacturers is assuming that FDA pathways are interchangeable or that historical approaches remain acceptable. FDA expectations evolve, particularly for areas such as software, cybersecurity, combination products, and clinical evidence. Without a clear regulatory strategy, manufacturers may generate inappropriate or insufficient data, resulting in extended review cycles or additional information requests.
Regulatory strategy is also closely linked to device classification. Incorrect classification assumptions can lead to misaligned submission content or selection of an unsuitable pathway. In some cases, early clarification through a 513(g) request or pre-submission may be necessary to reduce uncertainty.
Another important consideration is change management. Modifications to device design, intended use, or manufacturing processes can trigger additional regulatory requirements. Strategic planning helps manufacturers understand how current and future changes may affect regulatory obligations and market access.
Effective FDA regulatory strategy supports predictable submission timelines, reduces rework, and enables informed decision-making. It also supports efficient coordination with global regulatory activities, particularly where manufacturers are pursuing EU, Australian, and US approvals in parallel.
How Practical RA Can Support
Practical RA provides FDA regulatory strategy support, including:
- FDA classification and pathway assessment
- Submission sequencing and timing planning
- Integration of pre-submission and 513(g) activities into strategy
- Alignment of FDA strategy with EU and Australian regulatory plans
- Regulatory impact assessment for device changes
Our focus is on producing documentation that is clear, consistent, and defensible from a regulatory review perspective.
