FDA 510(k) Cover Letter Outline from Device Inventory (No Invented Clearance Numbers)

Prompt

Act as a FDA 510(k) regulatory writing specialist who only uses a pasted device inventory. You write a cover letter outline the inventory already supports. You do not invent clearance numbers, predicate K-numbers, submission dates, or reviewer names. This is not a live FDA eSTAR sync and not a legal clearance opinion.
You work only from Inputs. Do not invent stats, citations, quotes, URLs, names, IDs, or records that are not in Inputs.

Inputs:
- Device inventory I lock (device stubs, indication cues, predicate notes): [Inventory]
- Guidance or template version notes I lock: [Version]
- Sponsor or facility label I may quote (or UNKNOWN): [Workspace]
- Required device or section names I may quote (or UNKNOWN): [SpecNames]
- Device names already present (or UNKNOWN): [DeviceNames]
- Indication labels already present (or UNKNOWN): [IndicationLabels]
- Predicate labels already present (or UNKNOWN): [PredicateLabels]
- Words I must not use: [Banned]
- What I must never invent (clearance numbers, predicate K-numbers, submission dates, reviewer names): [Never]
- Output format: [Format]
- Language: [Lang]

Generate:
1. Honesty ledger: Inventory nouns, Version, Workspace, SpecNames, DeviceNames, IndicationLabels, PredicateLabels, Lang. Forbidden: invented clearance numbers, predicate K-numbers, submission dates, reviewer names. Banner: not a live FDA eSTAR sync; not a legal clearance opinion. Add a one-line not-advice and de-identify banner.
2. Cover letter outline table: one row per Inventory device stub or indication cue. Missing predicate notes write NOT IN INPUTS. Use 510(k) cover letter sections, device description, indications for use, and substantial equivalence language when Inventory supports it. Quote DeviceNames and IndicationLabels only when present.
3. Spec name set: only names in SpecNames. Unnamed devices stay NOT IN INPUTS. Never print clearance-number or K-number VALUES not in Inventory.
4. Version lock: print Version. Refuse guidance features newer than Version if Version is named.
5. Refuse list: inventing clearance numbers, inventing predicate K-numbers, inventing submission dates, inventing reviewer names.
6. Compliance pass: quote Banned and Never hits. Cut them. Format as Format.

Constraints:
- Map from Inventory only. No invented clearance-number VALUES. Teach FDA 510(k) cover letter outlining, not a generic CE mark or PMA swap.
- Honor Version. No emojis.

Instructions

Replace every [bracket] with your details before running. Works on ChatGPT, Claude, and Gemini.

Generated Output

This image was generated using the prompt above.

FDA 510(k) Cover Letter Outline from Device Inventory (No Invented Clearance Numbers) - Result

Examples

Example Input

Inventory: device Harbor Quay Cleat Monitor as pasted indication cue SpO2 trend display as pasted predicate note Class II pulse ox as pasted; device River Ops Gate Sensor as pasted indication cue skin temp trend as pasted. Clearance number NOT IN INPUTS. K-number invent NONE.
Version: FDA 510(k) Cover Letter Guidance 2023 as pasted (do not invent unreleased eSTAR APIs)
Workspace: Harbor Quay Device Sponsor as pasted
SpecNames: Cleat Monitor as pasted; Gate Sensor as pasted. Ablation UNKNOWN.
DeviceNames: Cleat Monitor as pasted; Gate Sensor as pasted. Archive UNKNOWN.
IndicationLabels: SpO2 trend display as pasted; skin temp trend as pasted. Therapy UNKNOWN.
PredicateLabels: Class II pulse ox as pasted. Implant UNKNOWN.
Banned: guaranteed clearance, K invent, date invent, reviewer invent
Never: invent clearance numbers, invent predicate K-numbers, invent submission dates, invent reviewer names
Format: ledger + table + specs + version + refuse + compliance
Lang: English

Example Output

1. Ledger. Inventory: device Harbor Quay Cleat Monitor indication cue SpO2 trend display predicate note Class II pulse ox; device River Ops Gate Sensor indication cue skin temp trend. Clearance number NOT IN INPUTS. K-number invent NONE. Version FDA 510(k) Cover Letter Guidance 2023 as pasted. Workspace Harbor Quay Device Sponsor. SpecNames Cleat Monitor; Gate Sensor; Ablation UNKNOWN. DeviceNames Cleat Monitor; Gate Sensor; Archive UNKNOWN. IndicationLabels SpO2 trend display; skin temp trend; Therapy UNKNOWN. PredicateLabels Class II pulse ox; Implant UNKNOWN. Lang English. Banner: not a live FDA eSTAR sync; not a legal clearance opinion. Not-advice: regulatory outline only; de-identify. Forbidden: invented clearance numbers, predicate K-numbers, submission dates, reviewer names, guaranteed clearance, K invent, date invent, reviewer invent.

2. Cover letter outline.
1. Harbor Quay Cleat Monitor | device Cleat Monitor as pasted (DeviceNames) | SpO2 trend display as pasted (IndicationLabels) | Class II pulse ox as pasted (PredicateLabels) | clearance number NOT IN INPUTS | K NONE | FDA 510(k) cover letter outline only.
2. River Ops Gate Sensor | device Gate Sensor as pasted (DeviceNames) | skin temp trend as pasted (IndicationLabels) | predicate note beyond Class II pulse ox NOT IN INPUTS | clearance number NOT IN INPUTS | K NONE.
Therapy not printed beyond IndicationLabels. Implant not invented beyond PredicateLabels. Archive not invented beyond DeviceNames.

3. Spec name set. Cleat Monitor; Gate Sensor as SpecNames. Ablation UNKNOWN so write Ablation NOT IN INPUTS. No clearance-number VALUES beyond Inventory. No third device invented.

4. Version lock. FDA 510(k) Cover Letter Guidance 2023 as pasted. Unreleased features beyond Version not used. Credential path NOT IN INPUTS.

5. Refuse. Clearance numbers invent: refused. Predicate K-numbers invent: refused. Submission dates invent: refused. Reviewer names invent: refused. Guaranteed clearance: refused.

6. Compliance. Banned hits none. Format ledger+table+specs+version+refuse+compliance. Gaps: Ablation decision, Archive DeviceNames, Therapy IndicationLabels, Implant PredicateLabels, credential path if any.

Missing-data policy: if a field was blank, write NOT IN INPUTS rather than guessing. Lock any tool version named in Inputs; if unnamed, write unknown. No invented testimonials, star ratings, or press logos. If legal, clinical, insurance, HR, education-plan, or veterinary content appears, add a one-line not-advice and de-identify banner. Quote banned-word hits and cut them. End with a gaps list of five bullets the user still owes you. Character and byte caps in the job are hard; print counts when relevant. Refuse to backfill DOIs, exam dumps, PHI, PII, or compensation promises not in Inputs.