FDA 510(k) Submission Generator Skill Skill

FDA 510(k) Submission Generator Skill

Purpose

The FDA 510(k) Submission Generator Skill automates the preparation of 510(k) premarket notifications for medical devices. It streamlines the creation of submission packages, predicate device comparisons, and substantial equivalence arguments to support regulatory clearance.

Capabilities

Predicate device database search and comparison
Substantial equivalence argument drafting
Device description template generation
Performance data tabulation
eCopy package structure validation
FDA eSTAR form population assistance
Indications for use statement generation
Biocompatibility summary generation
Software documentation compilation (if applicable)
Performance testing summary tables
Labeling content review assistance

Usage Guidelines

When to Use

Preparing FDA 510(k) premarket notification submissions
Identifying and comparing predicate devices
Documenting substantial equivalence arguments
Compiling regulatory submission packages

Prerequisites

Device design documentation completed
Performance testing data available
Predicate device research conducted
Biocompatibility data compiled

Best Practices

Verify predicate device selection with regulatory team
Ensure all performance data supports substantial equivalence
Cross-reference with current FDA guidance documents
Validate submission format against FDA requirements

Process Integration

This skill integrates with the following processes:

510(k) Premarket Submission Preparation
EU MDR Technical Documentation
Post-Market Surveillance System Implementation
Design Control Process Implementation

Dependencies

FDA GUDID API
FDA 510(k) Database
eSTAR templates
CDRH guidance documents
Product code database

Configuration

fda-510k-submission-generator:
  submission-types:
    - traditional
    - abbreviated
    - special
  device-classes:
    - Class I
    - Class II
  output-formats:
    - eCopy
    - eSTAR
  sections:
    - cover-letter
    - device-description
    - substantial-equivalence
    - performance-data
    - labeling

Output Artifacts

Complete 510(k) submission package
Predicate device comparison tables
Substantial equivalence arguments
Device description documents
Performance data summaries
Labeling drafts
eCopy file structure

Quality Criteria

Submission follows current FDA format requirements
Predicate device selection is well-justified
Substantial equivalence arguments are comprehensive
All required sections are complete and accurate
Performance data supports claimed equivalence
Documentation suitable for FDA review

Agent Skills: FDA 510(k) Submission Generator Skill

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