US FDA Class III Medical Device – PMA 

Simplified Roadmap

QMS-SR-US-FDA-MD(PMA)-RC3

Version: 07/18/2025

Prepared by: Dr. Vlad Reznikov

Date: July 18, 2025

Executive Summary

Class III devices require Premarket Approval (PMA). A Q‑Sub (Pre‑Submission) phase is essential to align on clinical and non‑clinical study expectations.

Estimated Timeline

≈ 3–7 years total, driven largely by clinical‑study duration.

Key Documents Checklist

Document Reference
Q‑Sub Packages (Pre‑Subs) FDA Q‑Sub Guidance
IDE Application 21 CFR 812
Clinical Study Reports ISO 14155 / GCP
PMA Volumes 1–4 21 CFR 814
Process Validation & Sterility 21 CFR 820
Post‑Approval Study Protocol PMA Order Conditions

Class iii timeline desc 2

Phase 0 – Strategy & Initial Q‑Sub (≈6 wks)

  • Define intended use; hold Pre‑Sub to discuss clinical pathway & endpoints.
  • Outline IDE requirements; set regulatory project plan.

Phase 1 – QMS Expansion & Design Controls (≈32 wks)

  • Establish full ISO 13485 / 21 CFR 820 QMS with design controls.
  • Compile DHF, DMR, process validation, human‑factors protocols.

Phase 2 – IDE Submission & Approval (≈8 wks)

  • Prepare IDE dossier; obtain IRB & FDA approvals.
  • Site initiation and training.

Phase 3 – Pivotal Clinical Investigation (≈104 wks)

  • Conduct multi‑site trial; periodic IDE reports.
  • Interim analyses and risk monitoring.

Phase 4 – PMA Compilation (≈16 wks)

  • Assemble PMA Volumes 1–4, draft summaries, pay user fee.
  • Pre‑Submission meeting for PMA filing strategy (optional).

Phase 5 – FDA Review & Panel (≈39 wks)

  • Address major/minor deficiencies; support advisory panel if convened.
  • Undergo Pre‑Approval Inspection (PAI).

Phase 6 – Approval & Launch (≈8 wks, then ongoing)

  • Fulfill post‑approval study commitments; submit PMA annual report.
  • Maintain heightened MDR and vigilance.