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Falcr

FDA regulatory second opinion

Get a second opinion on your FDA strategy.

A written assessment of your regulatory pathway, predicate options and evidence gaps, with supporting sources and recommended next steps. Before you commit to testing or submission work.

US$1,500 fixed fee · Written brief in two business days from the agreed start date.

One device. One intended use. One US FDA strategy question.

Request a second opinionView the brief

We assess agreed device facts without seeing your existing strategy. You compare the findings privately.

PUBLIC FDA EXAMPLE · DEXCOM · 2024

Same sensor hardware. Different evidence.

G7

Prescription

Stelo

Over the counter

Existing Dexcom testing applied

  • Biocompatibility
  • Sterilisation

Stelo‑specific testing

  • Buyer self‑selection
  • Safe use of the system

Which differences need evidence before you commit to testing?

A public FDA example, not a Falcr engagement.

Selected evidence: FDA K234070, pp. 3, 6, 19–20 (PDF, opens in a new tab).

Explore the example

WHEN IT HELPS

Before one assumption shapes what you build, test or submit.

For medical-device teams approaching a testing or strategy decision. Get a second opinion on the FDA question before more work depends on it. You keep working with your existing adviser.

  1. 01

    Before you commission testing.

    Check the pathway and evidence questions the test plan depends on.

  2. 02

    Before you rely on a predicate or pathway assumption.

    See whether an independent view reaches the same route and comparisons.

  3. 03

    Before you fix intended-use wording.

    Understand how the wording may affect classification, route and evidence.