Description
FDA PMA (Premarket Approval) Documentation
Comprehensive PMA documentation for FDA Class III high-risk medical device approval: a complete regulatory submission package demonstrating your device’s safety and effectiveness, prepared module by module. This service is for teams taking a Class III high-risk device through FDA premarket approval.
Service Details
| Turnaround | Standard: 20–30 weeks, depending on scope and complexity |
| Best for | FDA premarket approval of Class III high-risk medical devices |
| What you receive | A complete PMA submission package demonstrating safety and effectiveness: SSED, clinical study reports, nonclinical summaries, and labeling |
| Format | eCTD-like format – modular submission organization |
Regulatory Framework
- FDA 21 CFR 814 – Premarket Approval requirements
- FDA Guidance Documents – Device-specific guidance
- eCTD-like Format – Modular submission organization
- Quality Management System Regulation (QMSR) – 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
How It Works
- Send us your device information and the data and documents you already have
- We prepare the PMA documentation, module by module
- You review each draft and we revise based on your feedback
- You receive the final PMA documentation package, organized in modules
Which Service Do You Need?
This service covers the full PMA documentation package. If you need related device documentation on its own, see Instructions for Use (IFU) Development for healthcare professional and patient instructions for use, or Usability/Human Factors Study Report for formative and summative validation reports, use-related risk analysis, and the human factors engineering file.
Frequently Asked Questions
Which regulations and guidance does the documentation address?
FDA 21 CFR 814 premarket approval requirements, device-specific FDA guidance documents, and Quality Management System Regulation (QMSR, 21 CFR 820) compliance, organized in an eCTD-like modular format.
Does the package include clinical documentation?
Yes: clinical study reports, statistical analysis, adverse event summaries, and benefit-risk analysis, alongside the clinical investigations (IDE study reports) module.
Can you support FDA meetings and deficiency responses?
Yes. Additional services include pre-submission meeting support, panel meeting preparation, FDA deficiency responses, and PMA supplements.
How long does PMA documentation take?
The standard timeline is 20–30 weeks. The exact timeline depends on the scope and complexity of your submission.
Get started: add this service to your cart, or email co*****@*******se.com with a short description of your device and the data you have so far to discuss scope.
