Every sponsor eventually gets an FDA decision it disagrees with — a refuse-to-file, the finding underneath a complete response letter, a not-substantially-equivalent call, a clinical hold position that will not move. The reflex is to call the Ombudsman. That is usually the wrong first move: under 21 CFR 10.75, the Ombudsman mediates a broken conversation — it has no authority to reverse a decision. The mechanism that does is Formal Dispute Resolution, and it rewards sponsors who understood, long before they needed it, that the review runs entirely on the record they already built.

What the Ombudsman does, and does not, do

A 1998 amendment to 10.75(b)(2) gives a person who receives a Center's denial of a review request the ability to escalate that denial to FDA's Chief Mediator and Ombudsman. CDRH layers an informal version on top of that: its internal procedures expect stakeholders to work through Center staff, then management, then the CDRH Ombudsman, before they ever file a formal request for review. Both roles share a purpose — keeping disagreements from calcifying into a dispute that needs a formal record — and neither one has the authority to overturn a reviewer's scientific or regulatory conclusion. Treating an Ombudsman conversation as the appeal is the single most common way sponsors lose time they cannot get back; it is also why a decision that ultimately needs FDA meeting strategy built around it from the start rarely ends up needing a formal appeal at all.

10.75
The general FDA regulation governing internal review of agency decisions — the basis for every formal dispute resolution request.
3 levels
Division → office → center: the sequence CDER and CBER's joint guidance expects for drug and biologic appeals.
Administrative file
The review is bounded to what was already submitted — not an opening to introduce new data.

The center-specific paths

FDA does not run one appeals process; it runs several built on the same regulation. For drugs and biologics, CDER and CBER's joint guidance, Formal Dispute Resolution: Sponsor Appeals Above the Division Level, lays out a sequential escalation and interprets 10.75 alongside the IND dispute provision at 21 CFR 312.48 and the NDA/ANDA provision at 21 CFR 314.103. For devices, CDRH's own CDRH Appeals Processes guidance describes a different on-ramp — informal engagement first, formal review second — and has been under review by the Center since the Food and Drug Omnibus Reform Act, so confirm the current version before relying on its specifics.

  • CDER/CBER sponsors. Escalate the scientific or medical dispute to the division director, then the office director, then the center director — each level reviewing what the one below it already decided.
  • CDRH sponsors. Work the issue with Center staff and management, then the CDRH Ombudsman, before submitting a formal request for review; a refuse-to-file decision is a common trigger.
  • Either path. State whether the dispute is scientific, procedural, or both, whether informal resolution was already attempted, and what outcome is being requested — the guidance recommends all three, and reviewers notice when a request skips them.
  • Either path. A dispute arising from a CRL's underlying finding is reviewed the same way as any other scientific disagreement — the letter's classification doesn't change the escalation sequence.
The review is based on the administrative file. It is not a second chance to make the case you should have made the first time. Why the record is the whole game

Why the record decides the outcome before you ever file

Because review is bounded to the administrative file, a Formal Dispute Resolution request is not a venue for new evidence — it is a test of whether the record built during the original review already supports a different conclusion. Sponsors who treat every interaction with a division, from the first meeting through the response to a deficiency letter, as part of a file that might one day need to carry an appeal are the ones who actually win them. Sponsors who assemble their best argument only after an adverse decision are building a case for a forum that will not read it. The same discipline that makes a deliberate FDA regulatory strategy work before a decision is made is what makes an appeal work after one.

A dispute-resolution sequence to run before you need it
  1. Separate the process problem from the decision problem. A stalled review is an Ombudsman matter; a decision you disagree with is a Formal Dispute Resolution matter — conflating them wastes the clock.
  2. Confirm the administrative file is complete. Every argument and dataset you'd want considered needs to already be on the record, not assembled after the fact.
  3. Sequence the request through the correct chain. Division → office → center for CDER/CBER; staff → management → Ombudsman → formal review for CDRH.
  4. Write to the standard reviewers expect. Each issue stated plainly, its nature, the requested outcome, and whether informal resolution was already tried.

None of this requires a dramatic intervention. It requires building every submission as if it might one day need to support a formal review — and knowing, before the decision you disagree with ever arrives, which center's sequence applies and what the Ombudsman can and cannot do for you. Companies that learn the distinction only after a denial spend their first weeks relearning the regulation instead of building the case.

Frequently asked questions

Does going to the FDA Ombudsman count as filing an appeal?

No. The Ombudsman mediates communication and process problems — a stalled review, an unresponsive reviewer, a breakdown in dialogue. It has no authority to reverse a scientific or regulatory decision. To contest the decision itself, a sponsor requests Formal Dispute Resolution under 21 CFR 10.75, which starts review by the decision-maker's supervisor and, if unresolved, moves up the chain of command.

What can a Formal Dispute Resolution review actually consider?

The review is based on the information already in the administrative file — what was submitted and on the record when the decision was made. It is not an opportunity to introduce new data to change the outcome. The discipline that decides most appeals is building the record during the original interaction, not assembling one after an adverse decision.

Is the appeal process the same for drugs and devices?

No. CDER and CBER follow their joint guidance, Formal Dispute Resolution: Sponsor Appeals Above the Division Level, escalating from division director to office director to center director. CDRH follows its own CDRH Appeals Processes guidance, which generally expects engagement with Center staff, then management, then the CDRH Ombudsman, before a formal request for review. Confirm the current version of the relevant center's guidance before filing.

Sources & further reading

  1. 21 CFR 10.75 — Internal agency review of decisions. ecfr.gov
  2. FDA. Formal Dispute Resolution: Sponsor Appeals Above the Division Level — Guidance for Industry and Review Staff. fda.gov
  3. FDA. Center for Devices and Radiological Health (CDRH) Appeals Processes — Guidance for Industry and FDA Staff. fda.gov

This article is provided for general informational purposes and reflects the regulatory landscape as of October 2026. It is not legal or regulatory advice. Confirm the current version of the applicable center's dispute-resolution guidance with FDA or qualified counsel before acting.