Compare +50 FDA 522 Postmarket Surveillance Providers

If your team received, expects, or is risk-planning for a Section 522 order, this directory page helps you shortlist providers with the right depth in clinical operations, real-world data, epidemiology, and FDA communication support. Use the calculators below first so you start provider calls with a clear scope, assumptions, and budget guardrails.

Start With These 6 Practical Planning Tools

522 Applicability & Risk Calculator 522 Sample Size & Timeline Calculator 522 Program Budget Calculator 522 Site Feasibility Calculator 522 Protocol Amendment Impact Calculator 522 Data Quality Remediation Calculator

These tools are planning aids and not legal advice. They help teams structure assumptions before formal provider proposals and FDA interactions.

What Makes a High-Quality 522 Provider

High-performing providers usually combine regulatory strategy, protocol design, data operations, and safety reporting execution in one coordinated operating model. In practice, this means your team should expect clear ownership from study concept through final report delivery, not fragmented handoffs between disconnected vendors.

At a minimum, evaluate a provider on five dimensions: prior exposure to Section 522 programs and FDA postmarket requests; rigor in protocol writing and endpoint definition; data quality controls and audit readiness; communication discipline for FDA-facing deliverables; and operational adaptability if assumptions change after early enrollment or interim review.

Ask for concrete examples of how the provider has handled enrollment shortfalls, adverse event signal escalation, and protocol amendments. A provider with mature execution discipline should be able to explain how these events were detected, triaged, documented, and communicated, with explicit timelines and accountability.

Provider Comparison Criteria You Should Use

Regulatory Fit

Can they map your product risk profile to Section 522 scope and 21 CFR Part 822 expectations with evidence-based rationale?

Protocol Quality

Do they define endpoints, analysis plans, and data governance in a way that is review-ready and internally auditable?

Data Operations

Can they show monitoring plans, query workflows, and source data verification methods tied to measurable quality thresholds?

Execution Cadence

Do they run with predictable milestones, escalation routes, and sponsor visibility on schedule, quality, and cost variance?

Reporting Discipline

Can they deliver coherent interim/final reports that align methods, findings, and benefit-risk interpretation without gaps?

Cost Transparency

Do they separate fixed setup, variable per-site/per-patient costs, and contingencies so scope changes are explainable?

How Teams Use This Directory Page

Estimate order likelihood and complexity with the applicability calculator.
Estimate study design pressure and site-network feasibility.
Model program-level budget and data-remediation workload assumptions.
Stress-test amendment impact before locking protocol changes.
Use consolidated outputs as your baseline when comparing providers and statements of work.

Teams that run this sequence usually shorten provider selection cycles because assumptions are explicit before proposal review begins.

Core Regulatory References

[1] FDA, Postmarket Surveillance Under Section 522 of the FD&C Act: official overview.
[2] eCFR, 21 CFR Part 822 (Postmarket Surveillance): regulatory text.
[3] FDA, Medical Device Reporting (21 CFR Part 803) resources: MDR framework.

Before provider selection, many teams also review: