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Follow a mandated device study from order to evidence
Use FDA 522 postmarket-surveillance records through PS numbers, orders, objectives, protocols, populations, progress reports, status definitions, final assessments and program boundaries.
Some medical-device questions only become visible after products enter wider or longer use. Section 522 of the Federal Food, Drug, and Cosmetic Act allows FDA to order postmarket surveillance for certain devices, creating a defined study obligation and public record.
The 522 database connects a PS number with the device, manufacturer, order date, study objective, protocol and progress. Those fields let a student follow how a regulatory question becomes a study and how that study changes over time.
Did you know? A surveillance order is not proof that a device caused an adverse outcome. It signals that FDA requires additional postmarket information, and the strength of later conclusions depends on the design and results.
This guide teaches postmarket-study literacy. It does not interpret an individual patient’s device, replace current FDA communications or provide medical advice.
Chapter index
Chapters 1–9: order identity, objectives and design
- 1. Section 522 gives FDA surveillance authority
- 2. An order does not itself prove a defect
- 3. The PS number anchors a study record
- 4. The order date starts the regulatory timeline
- 5. Study objectives define the evidence question
- 6. Study design determines what can be learned
- 7. Population and device scope must match
- 8. Protocol status is a process milestone
- 9. Enrollment status differs from protocol status
Chapters 10–17: status, reporting, final evidence and program boundaries
- 10. Interim reports update progress
- 11. Final status needs the final report
- 12. Status can change with new information
- 13. Market withdrawal can alter the study
- 14. 522 studies differ from PMA postapproval studies
- 15. 522 studies differ from MAUDE reports
- 16. Study results need method-aware reading
- 17. Surveillance literacy supports public health careers
A Section 522 order turns a postmarket question into a documented surveillance obligation. Under section 522 of the FD&C Act, FDA may require certain manufacturers to conduct postmarket surveillance for specified devices. This helps learners follow evidence after marketing without treating a study order as proof of harm.
Try this
Evidence question: Which statutory authority is named? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Record the order and device category before discussing the study. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. Keep the identifier, retrieval date and source page in the note so the route can be repeated.
Evidence checkpoint
Record the evidence object for section 522 gives fda surveillance authority, its identifier or version context, and one limit that must remain visible.
The public study database connects a device, order date, study plan and progress information. A surveillance order identifies a question requiring postmarket study; it should not be translated into a finding that the device caused harm. It also distinguishes a mandated surveillance study from a spontaneous adverse-event report.
Try this
Evidence question: What question is FDA asking? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Write the order objective without adding a conclusion. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. If a field is missing, write “not shown” and follow the official documentation rather than inventing a value.
Evidence checkpoint
Record the evidence object for an order does not itself prove a defect, its identifier or version context, and one limit that must remain visible.
Postmarket surveillance complements premarket review because some questions require wider use or longer follow-up. The public database assigns a postmarket surveillance study identifier that links the order, device, manufacturer and study details. The PS number and study page make the route auditable.
Try this
Evidence question: Which PS number supports the statement? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Save it with the access date. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. Before comparing two records, check that their object types, methods, versions and units really align.
Evidence checkpoint
Record the evidence object for the ps number anchors a study record, its identifier or version context, and one limit that must remain visible.
CHAPTER 4 OF 17 · Identify the order
4. The order date starts the regulatory timeline
Study status is a process label that needs the protocol, dates and FDA assessment around it. The order date records when FDA required surveillance. Protocol submission, approval and study milestones occur later. Clinical interpretation still depends on the study design and current FDA communication.
Try this
Evidence question: Which event belongs to each date? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Build an ordered timeline. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. Finish by naming one supported statement and one stronger statement that still needs another evidence layer.
Evidence checkpoint
Record the evidence object for the order date starts the regulatory timeline, its identifier or version context, and one limit that must remain visible.
A Section 522 order turns a postmarket question into a documented surveillance obligation. The record states the purpose of surveillance, such as assessing outcomes, use conditions or longer-term performance in a defined population. This helps learners follow evidence after marketing without treating a study order as proof of harm.
Try this
Evidence question: What endpoint or uncertainty is targeted? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Restate the objective in plain language and retain its scope. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. Keep the identifier, retrieval date and source page in the note so the route can be repeated.
Evidence checkpoint
Record the evidence object for study objectives define the evidence question, its identifier or version context, and one limit that must remain visible.
The public study database connects a device, order date, study plan and progress information. Registries, prospective cohorts, retrospective analyses, surveys and other designs answer different questions and carry different biases. It also distinguishes a mandated surveillance study from a spontaneous adverse-event report.
Try this
Evidence question: Which design was approved? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Name its comparison group, follow-up and main limitation. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. If a field is missing, write “not shown” and follow the official documentation rather than inventing a value.
Evidence checkpoint
Record the evidence object for study design determines what can be learned, its identifier or version context, and one limit that must remain visible.
Postmarket surveillance complements premarket review because some questions require wider use or longer follow-up. A surveillance order can apply to a device type or specified products, uses or patient groups. Broadening the population changes the question. The PS number and study page make the route auditable.
Try this
Evidence question: Which patients and device versions are included? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Copy inclusion boundaries into the evidence note. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. Before comparing two records, check that their object types, methods, versions and units really align.
Evidence checkpoint
Record the evidence object for population and device scope must match, its identifier or version context, and one limit that must remain visible.
Study status is a process label that needs the protocol, dates and FDA assessment around it. FDA evaluates surveillance plans and may identify them as approved, pending, inadequate or in another procedural state described by current guidance. Clinical interpretation still depends on the study design and current FDA communication.
Try this
Evidence question: What does the displayed status mean on this record date? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Check the official status definition before interpreting it. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. Finish by naming one supported statement and one stronger statement that still needs another evidence layer.
Evidence checkpoint
Record the evidence object for protocol status is a process milestone, its identifier or version context, and one limit that must remain visible.
CHAPTER 9 OF 17 · Follow study progress
9. Enrollment status differs from protocol status
A Section 522 order turns a postmarket question into a documented surveillance obligation. A study can have an approved plan while enrollment is delayed, ongoing, complete or not applicable. The fields answer separate questions. This helps learners follow evidence after marketing without treating a study order as proof of harm.
Try this
Evidence question: Which operational milestone is being reported? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Keep protocol and enrollment columns separate. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. Keep the identifier, retrieval date and source page in the note so the route can be repeated.
Evidence checkpoint
Record the evidence object for enrollment status differs from protocol status, its identifier or version context, and one limit that must remain visible.
The public study database connects a device, order date, study plan and progress information. Manufacturers submit periodic reports, and FDA assessments can describe milestones, problems and recommended actions. It also distinguishes a mandated surveillance study from a spontaneous adverse-event report.
Try this
Evidence question: Which reporting period does the assessment cover? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Record the report date and observed progress. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. If a field is missing, write “not shown” and follow the official documentation rather than inventing a value.
Evidence checkpoint
Record the evidence object for interim reports update progress, its identifier or version context, and one limit that must remain visible.
Postmarket surveillance complements premarket review because some questions require wider use or longer follow-up. Completion of enrollment or follow-up is not the same as FDA’s final assessment of study results. The PS number and study page make the route auditable.
Try this
Evidence question: Has a final report been submitted and reviewed? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Link the conclusion to the final assessment. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. Before comparing two records, check that their object types, methods, versions and units really align.
Evidence checkpoint
Record the evidence object for final status needs the final report, its identifier or version context, and one limit that must remain visible.
Study status is a process label that needs the protocol, dates and FDA assessment around it. Database records evolve as protocols, progress reports and FDA evaluations change. A screenshot without an access date can become misleading. Clinical interpretation still depends on the study design and current FDA communication.
Try this
Evidence question: When was the record retrieved? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Save a dated evidence receipt. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. Finish by naming one supported statement and one stronger statement that still needs another evidence layer.
Evidence checkpoint
Record the evidence object for status can change with new information, its identifier or version context, and one limit that must remain visible.
CHAPTER 13 OF 17 · Interpret results and limits
13. Market withdrawal can alter the study
A Section 522 order turns a postmarket question into a documented surveillance obligation. If a manufacturer ceases distribution, FDA may revise expectations or record how that affects surveillance. The order history provides context. This helps learners follow evidence after marketing without treating a study order as proof of harm.
Try this
Evidence question: Did market status change the objective or feasibility? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Follow the documented decision. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. Keep the identifier, retrieval date and source page in the note so the route can be repeated.
Evidence checkpoint
Record the evidence object for market withdrawal can alter the study, its identifier or version context, and one limit that must remain visible.
CHAPTER 14 OF 17 · Interpret results and limits
14. 522 studies differ from PMA postapproval studies
The public study database connects a device, order date, study plan and progress information. Both can generate postmarket evidence, but their authority, identifiers, databases and obligations differ. It also distinguishes a mandated surveillance study from a spontaneous adverse-event report.
Try this
Evidence question: Is this a 522 study or a PMA postapproval study? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Use the correct program name and record number. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. If a field is missing, write “not shown” and follow the official documentation rather than inventing a value.
Evidence checkpoint
Record the evidence object for 522 studies differ from pma postapproval studies, its identifier or version context, and one limit that must remain visible.
CHAPTER 15 OF 17 · Interpret results and limits
15. 522 studies differ from MAUDE reports
Postmarket surveillance complements premarket review because some questions require wider use or longer follow-up. A planned surveillance study uses a protocol and defined population; MAUDE contains individual reports with known denominator and reporting limitations. The PS number and study page make the route auditable.
Try this
Evidence question: Which data-generating process produced the evidence? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Do not combine counts as if they were one dataset. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. Before comparing two records, check that their object types, methods, versions and units really align.
Evidence checkpoint
Record the evidence object for 522 studies differ from maude reports, its identifier or version context, and one limit that must remain visible.
CHAPTER 16 OF 17 · Interpret results and limits
16. Study results need method-aware reading
Study status is a process label that needs the protocol, dates and FDA assessment around it. An association, event rate or outcome estimate depends on sampling, follow-up, missing data, analysis and device exposure. Clinical interpretation still depends on the study design and current FDA communication.
Try this
Evidence question: Which design feature limits generalisation? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Write a method-result-limit triad. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. Finish by naming one supported statement and one stronger statement that still needs another evidence layer.
Evidence checkpoint
Record the evidence object for study results need method-aware reading, its identifier or version context, and one limit that must remain visible.
CHAPTER 17 OF 17 · Interpret results and limits
17. Surveillance literacy supports public health careers
A Section 522 order turns a postmarket question into a documented surveillance obligation. Epidemiologists, statisticians, clinicians, engineers and regulators collaborate to answer postmarket questions over time. This helps learners follow evidence after marketing without treating a study order as proof of harm.
Try this
Evidence question: Which role owns each evidence step? Answer in three parts: identify the visible field or file, explain how it bears on the question, and state the boundary of that evidence. Preserve the database’s own object names and accession rather than flattening everything into the word ‘data’.
Try this: Prepare a PS-number study map. Turn the result into a compact claim-evidence-reasoning note, then ask a partner to retrace it. Keep the identifier, retrieval date and source page in the note so the route can be repeated.
Evidence checkpoint
Record the evidence object for surveillance literacy supports public health careers, its identifier or version context, and one limit that must remain visible.
Contents · Previous chapter · Continue at the Science Learning Hub
A surveillance claim becomes reliable when the order, protocol and status date travel together
The 522 database makes a continuing study process visible. Students can see the difference between an order, an approved plan, operational progress, interim assessment and completed evidence.
Save the PS number, device, manufacturer, product code, order date, objective, study design, population, protocol status, enrollment status, report date, FDA assessment, final status, linked program and access date.
| Reading object | What it can support | Question to keep visible |
|---|---|---|
| PS number | Identity of one 522 surveillance study | Which order and device connect? |
| Study objective | Postmarket question FDA requires the study to address | Which endpoint and population? |
| Protocol status | FDA assessment of the proposed or active plan | What definition and date apply? |
| Final assessment | FDA evaluation after study completion | Which results and limits support the conclusion? |
Sources and next reading
Substantive resource claims in this article were checked against the primary pages below. A structured record is a route into evidence; it does not by itself prove a scientific conclusion. Recheck the live record, evidence labels and release context before using it in assessed work or research.
For a classroom enquiry, save a short research receipt containing the question, search terms, selected object, exact identifier, version, access date and the evidence boundary you observed. Add the file or page that supports each statement. This small routine turns browsing into accountable science learning and gives a teacher, classmate or future analyst a route they can independently follow.
Before sharing the conclusion, ask another reader to retrace the route without verbal hints. If they reach a different version, file or interpretation, improve the receipt and narrow the claim. Reproducibility begins with this practical check. It teaches careful reading, supports fair collaboration and keeps uncertainty visible while evidence moves from an online service into notes, analysis and a final explanation.
A useful final review separates five questions. What object was found? Which organisation or repository maintains it? What exact evidence was inspected? Which statement does that evidence support? What remains uncertain? Answer each question in one sentence, then connect every answer to a visible field, file or source page. This review catches common mistakes: citing a collection when a file supplied the value, treating the newest release as the analysed release, confusing permission with scientific suitability, or turning a discovery count into a conclusion. It also gives students a calm way to improve work. A missing detail becomes a next research step instead of an invitation to guess. When the route is complete, the final explanation can stay simple because the identifiers, dates, versions, limitations and supporting evidence are already organised underneath it.
Primary sources
- FDA 522 Postmarket Surveillance Studies Database — accessed 25 October 2026.
- Postmarket Surveillance Under Section 522 — accessed 25 October 2026.
- 522 Postmarket Surveillance Studies Program — accessed 25 October 2026.
- Postmarket Surveillance Guidance — accessed 25 October 2026.
- FDA Postmarket Requirements for Devices — accessed 25 October 2026.