[ 05 · BUILDING THE EVIDENCE ]

Preparing questions and evidence for a regulator meeting

“I can request a meeting with the agency. What do I ask, and what will they expect me to already know?”

A pre-submission meeting is the cheapest regulatory advice available and the most commonly wasted. The agency answers the questions you ask, in the context you provide — so the value is set almost entirely by the briefing package, and by whether you asked something specific enough to be answerable.

WHAT THIS IS NOT

Orientation for translating research toward a regulated product — not a determination of device status, regulatory pathway, submission type or clinical adequacy, and not a substitute for qualified regulatory advice. SPEQ is independent: linked institutions, incubators and agencies are third parties, and nothing here implies affiliation, endorsement or partnership with any of them.

ARE YOU HERE?

  • You have an intended use, some data, and a plan you are not certain about
  • The questions in your head are open-ended — "is this the right pathway?" — rather than answerable
  • Nobody on the team has written a briefing package before

WHAT TO DECIDE NOW

  • The specific decisions you need agency input on, phrased so that a yes or a no changes what you do next
  • What you will propose rather than what you will ask. A meeting that presents a plan for comment goes better than one that asks to be told the plan.
  • Which questions you are NOT asking because you already hold the answer, so meeting time is not spent confirming it

START KEEPING THESE RECORDS NOW

  • The briefing package as sent, with its data cut-off, because the advice you receive is advice on that package
  • The agency’s written responses and the meeting minutes, which become the reference point for every later decision that relies on them
  • Your own record of what you committed to in the meeting, which is easy to under-record and is remembered

THE PROBLEM THIS ANSWERS

FDA publishes several distinct assistance and interaction programs, each scoped to a product class and a stage, and a first-time sponsor cannot map their own situation onto that structure.

What it costs: Either no interaction happens until it is forced, or the wrong program is approached and the time spent produces no usable feedback.

NOT YET MEASURED — Arrivals on the regulator-meeting guide from program-name queries rather than from generic FDA queries.

WHERE THIS GOES WRONG

  • Asking the agency to choose your pathway. They respond far better to a reasoned proposal than to an open question, and an open question often returns an answer you cannot act on.
  • Submitting a briefing package that omits the weakness you are worried about. The gap is usually visible, and raising it yourself is the cheaper version.
  • Treating meeting feedback as permanent. It reflects the package and the policy at that date, and both change.

WHAT THIS DOES NOT ANSWER

  • Whether the meeting type you are eligible for is the one you want, which depends on the product and the programme stage
  • How binding the feedback is — advice is not approval, and agency positions can move as evidence and policy do

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