FDA PMA Documentation (Class III)

FDA PMA Documentation (Class III)

$75,000

Comprehensive FDA PMA documentation for Class III medical device approval. SSED, clinical study reports, nonclinical summaries, and labeling. Complete premarket approval submission package.

SKU: EV-MD-002 Category:

Description

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FDA PMA (Premarket Approval) Documentation

Comprehensive PMA documentation for FDA Class III high-risk medical device approval. Complete regulatory submission package demonstrating safety and effectiveness.

Regulatory Framework

  • FDA 21 CFR 814 – Premarket Approval requirements
  • FDA Guidance Documents – Device-specific guidance
  • eCTD-like Format – Modular submission organization
  • Quality System Regulation (QSR) – 21 CFR 820 compliance

PMA Modules

  • Administrative and device information
  • Summary of Safety and Effectiveness Data (SSED)
  • Device description and principles of operation
  • Manufacturing information
  • Nonclinical laboratory studies
  • Clinical investigations (IDE study reports)
  • Labeling
  • Environmental assessment

Clinical Documentation

  • Clinical study reports
  • Statistical analysis
  • Adverse event summaries
  • Benefit-risk analysis

Additional Services

  • Pre-submission meeting support
  • Panel meeting preparation
  • FDA deficiency responses
  • PMA supplements

Timeline

Standard: 20-30 weeks | Scope and complexity dependent

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