| name | 510k-premarket-notification |
| title | FDA 510(k) Premarket Notification |
| description | Drafts FDA 510(k) Premarket Notification submissions demonstrating substantial equivalence under 21 CFR Part 807. Supports Traditional, Special, and Abbreviated pathways. Use when preparing Class II medical device regulatory filings, substantial equivalence analyses, or FDA premarket submissions. |
| author | CaseMark |
| author_url | https://github.com/CaseMark/skills/tree/main/skills/legal/510k-premarket-notification |
| license | Apache-2.0 |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | us |
| practice | life-sciences |
| language | en |
| tags | ["drafting","letter"] |
FDA 510(k) Premarket Notification
Drafts a complete 510(k) submission package demonstrating substantial equivalence to a predicate device under 21 CFR Part 807, Subpart E.
Prerequisites
Gather before drafting:
- 510(k) type — Traditional, Special, or Abbreviated
- Predicate device — trade name, manufacturer, K-number, clearance date
- Device classification — product code, regulation number, panel, class
- Establishment registration — FDA registration number; U.S. agent if foreign
- Technical file — drawings, materials list, software architecture (if applicable)
- Performance data — bench testing, biocompatibility (ISO 10993), clinical/literature evidence
- Proposed labeling — IFU, package insert, patient materials, packaging artwork
Submission Sections
1. Cover Letter
Address to appropriate CDRH division. Include device trade name + common name, 510(k) type, predicate (name, manufacturer, K-number), pathway justification (why 510(k) vs. PMA), submitter contact with establishment registration, and U.S. agent if foreign manufacturer.
2. FDA Form 3514
Complete all fields: applicant legal name and FDA registration number, trade name + common name, product code / regulation number / panel / class, submission type (original or resubmission with prior K-number), 510(k) type, disclosure election (Summary or Statement), contact info, and signature block with authorized representative.
3. Device Description
Enable reviewer comprehension without physical examination:
- Physical characteristics — size, weight, configuration
- Materials — flag patient-contacting materials with ISO 10993 status
- Operating principles and mechanism of action
- Software/firmware, cybersecurity, AI/ML components (if applicable)
- Energy source and safety controls (if applicable)
- Sterility method and SAL (if sterile)
- Novel features — each must be addressed in SE comparison
Reference engineering drawings, cross-sections, and annotated photos.
4. Intended Use & Indications for Use
- Intended use — general purpose, broad clinical condition
- Indications — patient population, specific conditions, anatomical site, selection criteria
- Contraindications — patients/conditions where device should not be used
Critical: IU language must be identical across labeling, submission, and Form 3514. Any divergence from predicate IU requires justification. Every indication must be supported by performance data.
