Regulatory Strategy & Pathway
Pathway determination shapes everything downstream: testing scope, submission type, timeline, and cost. FDA evaluates 510(k)s against substantial equivalence to a predicate, while PMA and De Novo carry their own evidentiary standards. Getting this right before development begins means building toward the right evidence from day one.
- FDA pathway strategy and submission planning
Determining whether a device qualifies for 510(k), De Novo, or PMA shapes the entire regulatory timeline and testing burden. We assess your device against current classification precedent and FDA's own decision logic before you commit resources to a pathway.
- Device classification, product code assessment, and 510(k) exemption analysis
Getting the product code wrong early cascades into the wrong predicates, the wrong testing expectations, and the wrong review timeline. We identify the correct classification regulation and product code, and check whether your device qualifies for a 510(k) exemption before you assume a full submission is required.
- Combination product determination and RFD support
Devices that include a drug or biologic component require a Request for Designation to establish which FDA center leads review. We help determine whether your product is a combination product under 21 CFR 3.2(e) and prepare the RFD submission where needed.
- Applicable consensus standards identification and Declaration of Conformity
FDA increasingly expects submissions to reference recognized consensus standards rather than justify testing from first principles. We identify which standards apply to your device and prepare Declarations of Conformity that hold up under review.
- Predicate search, intended use alignment, and substantial equivalence narrative
A 510(k) succeeds or fails on the strength of its substantial equivalence argument. We search for predicates that genuinely support your intended use, then build the comparison narrative the way a reviewer expects to see it argued, not just asserted.
- Breakthrough Device Designation
Qualifying requires meeting two criteria: the device must address a life-threatening or irreversibly debilitating condition, and satisfy at least one of four secondary criteria showing meaningful advantage over the standard of care. FDA decides within 60 days of a complete request, and designation doesn't reduce the evidence required, it can shift some of it to the post-market phase. We prepare requests that make both parts of that case on the agency's own terms.
- 513(g)
When classification is genuinely unclear, a 513(g) gets FDA's formal position in writing before you build a regulatory strategy on an assumption. We prepare the request and the supporting rationale.