Pricing & scope
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.
Scope and delivery
FIXED FEE
US$1,500 fixed fee
Written brief in two business days from the agreed start date
SCOPE
- One device or configuration
- One proposed intended use
- US FDA
- One agreed strategy question
INCLUDED
- The Regulatory Pathway Brief
- Supporting cited analysis
- A short findings discussion
HOW THE DATES WORK
- Start date
- Agreed with you once your inputs are complete, the scope is accepted and qualified-review capacity is secured.
- Written brief
- Due two business days from that agreed start date.
- Findings discussion
- Scheduled separately.
- Review before acceptance
- We accept a project only once qualified review is secured for your question. If it cannot be, we tell you before any paid work begins.
Additional devices, intended uses, markets or questions need separate scope.
A planning input: not a regulator’s decision.
What it is
- An independent view of one agreed US FDA question, built from agreed non-confidential inputs and public regulatory sources.
- A source-linked assessment of likely classification, premarket route, relevant public device records and evidence questions, with assumptions and open issues stated.
- A planning input for deciding what deserves another look or formal confirmation.
What it is not
- A determination or opinion of a regulator, notified body, conformity assessment body or authorised representative.
- Legal or formal regulatory advice.
- A dossier, submission, authority engagement or conformity assessment.
- A guarantee of a regulator’s classification, pathway or approval decision, evidence acceptance, regulatory review timelines, or third-party testing and programme costs.
- A replacement for the manufacturer’s own legal and regulatory responsibilities.