510k-premarket-notification
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
More from casemark/skills
amicus-coalition-management
Manages multi-organization appellate amicus briefs with single-pen drafting, coalition sign-offs, conflict triage, and compliant disclosures. Use when coordinating a coalition amicus brief, managing amicus sign-on, handling FRAP 29 or Supreme Court Rule 37.6 disclosures, or preparing cover and interest sections for multiple amici.
2amicus-interest-statement
>
2amended-restated-certificate
Drafts a Delaware Amended and Restated Certificate of Incorporation implementing VC term sheet economics and governance into DGCL-compliant charter provisions. Use when drafting or revising a Delaware A&R certificate, preferred stock charter terms, Series Seed/A/B financing charter, blank check preferred authority, or implementing cap structure from a term sheet or SPA.
2amicus-brief
Drafts and analyzes U.S. appellate amicus curiae briefs for non-parties with Rule 29/Rule 37 compliance, unique perspective development, and Bluebook-ready citations. Use when asked to draft or review an amicus brief, friend-of-the-court brief, non-party brief, or anything involving FRAP 29, Supreme Court Rule 37, or appellate amicus practice.
2adoption-summary
>-
2appeal-summary
Generates structured analytical summaries of appellate documents covering procedural posture, issues on appeal, standards of review, and strategic assessment. Use when onboarding to an appeal, preparing for oral argument, evaluating appellate risk, or summarizing the appellate record.
2