510(k) strategy brief: proposed use, comparison and evidence responsibilities
The acquired 21 CFR 807.87 specifies submission-content topics; 807.92 distinguishes the content of a 510(k) summary, and 807.97 addresses misleading references to notification. Scope the proposed indication, technological comparison and evidence gaps before commissioning preparation. A shared product code or a public summary does not establish a suitable predicate.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Sourced criteria · US
What changes the service scope?
Decision or task
What the source describes
What to prepare
Which proposed device and use are being described?
Section 807.87 includes device identification, classification, labeling and intended-use information among submission-content topics. [1]
Prepare the actual proposed labeling, design and existing classification rationale; flag unresolved route questions.
What does the comparison need to explain?
Section 807.92 describes summary information concerning use and technological characteristics and relevant comparison context. [2]
Build a named-record comparison with actual differences and evidence access; review comparator suitability separately.
Which evidence is already available?
The acquired submission-content and summary provisions describe evidence information; a public summary is not the complete underlying dossier. [1][2]
Inventory source reports, methods, limitations and missing work; quote testing packages only after their need is justified.
What can the engagement claim?
Section 807.97 addresses misleading representations associated with premarket notification. [3]
Agree accurate submission/clearance language and the deliverables the provider controls; avoid guaranteed success or representing premarket notification as official approval.
The buyer route, exemptions, complete current requirements and predicate suitability remain unresolved. The cited provisions do not certify another device or provide a clearance probability.
A scoped evidence and handoff plan
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Which proposed device and use are being described?
Prepare the actual proposed labeling, design and existing classification rationale; flag unresolved route questions.
Useful evidence: Proposed indications/labeling, design description and classification/route rationale.
What does the comparison need to explain?
Build a named-record comparison with actual differences and evidence access; review comparator suitability separately.
Useful evidence: Named records and an indication/design/evidence differences matrix.
Which evidence is already available?
Inventory source reports, methods, limitations and missing work; quote testing packages only after their need is justified.
Agree accurate submission/clearance language and the deliverables the provider controls; avoid guaranteed success or representing premarket notification as official approval.
Useful evidence: Engagement scope, exclusions and reviewed product/marketing claims.
Work packages and dependencies
Conditional: Proposed-use, route and evidence-gap strategy before submission preparation — For this work package, agree the supported criteria, evidence access, covered entities/products and unresolved facts in the table above. Additional services require their own justified scope.
Questions for providers
Which exact actor, product or processing facts support the quoted scope, and what is still unresolved?
How will the listed records reach the responsible people, and who owns each change or authority request?
Which tasks and entities are excluded from the agreement, and which additional services need a separate assessment?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
