Disagreeing with a call your team is about to make — an SE determination, a labeling claim, a risk classification — is a normal part of the job. What separates people who get invited back into the next hard conversation is how they raise it, not whether they turned out to be right.
Make the objection specific before you make it out loud
“I’m not comfortable with this” is a feeling, not an objection, and it gives a team nothing to work with. “I don’t think this predicate supports substantial equivalence because the technological characteristics differ in this specific way” is an objection — it names the finding under 21 CFR 807.100 you’d weigh differently and why. Write that sentence down before the meeting where you plan to raise it. If you can’t write a specific version of it, you probably aren’t ready to raise it yet, and saying so out loud anyway usually reads as friction rather than as a contribution.
This isn’t about being right before you speak. It’s about making sure the team is disagreeing with a finding, not managing your discomfort. Those are different conversations, and only one of them is worth the room’s time.
Raise it before the decision, not after
Timing changes what the conversation is. Raised during internal deliberation, a specific objection is one input among several the team is still weighing. Raised after a submission has gone in, it’s a much harder and more expensive conversation, because the decision now has a paper trail and a clock attached to it. Say what you think while the decision is still being made, not after it’s been made without you.
If you make the case and the team decides differently anyway, the professional move is to note your input briefly in the record and then execute the decision the team actually made. Relitigating a settled call in every subsequent meeting costs you more credibility than being overruled once ever did — and it makes the next person less likely to bring you a hard call at all.
Where this goes wrong
Raising a vague objection with no specific alternative
“Something feels off” gives a team nothing to evaluate and nothing to act on.
Waiting until after the decision ships to say something
The same objection lands very differently once there’s a submission, a letter, or a filed record behind the decision.
Escalating over a manager’s head after being overruled once
One disagreement, aired and heard, is normal disagreement; skipping the chain the first time you lose an argument reads as something else.
Being right isn’t what earns you a seat at the next hard call — being someone whose disagreement is specific, timely, and easy to work with is. Make the case once, make it well, and let the decision be the team’s, not just yours.
Sources & further reading
- 21 CFR 807.100 — Premarket notification, FDA action on a submission ecfr.gov
- Regulatory Academy — How to Explain a Regulatory Decision regulatoryacademy.com
- Regulatory Academy — The Case for a Regulatory Decision Log regulatoryacademy.com
This essay is provided for general educational purposes and reflects the regulatory landscape as of its publication date. It is not legal, regulatory, or career advice.
