Consultants specialising in regulatory affairs




PMA (Premarket Approval)


Premarket approval is the FDA process to evaluate a Class III device. This classification has the most stringent review and is reserved for those devices, blood devices or biologics that support or sustain human life, or may have substantial impact on human health, or present a potential for risk or illness. Class III devices are reviewed with exacting scrutiny by the FDA.

We have the experience to guide your company through this process. As consultant for MedMira of Canada, MedMira has received their PMA for a Rapid HIV Test Kit.

We can assist you in determining what PMA approach best suits your product:

  • Traditional PMA
  • Modular PMA
  • Streamlined PMA
  • Product Development Process
  • Humanitarian Device Exemption

We will assist your company in meeting the following mandatory PMA requirements:

  • Required Elements

    • Device Description
    • Alternative Practices and Procedures
    • Marketing History
    • Summary of Studies
    • Conclusions Drawn from the Studies
    • Results of Nonclinical Laboratory Studies
    • Results of Clinical Investigations Involving Human Subjects
    • Other Information
    • Omissions
    • Updates
  • Required PMA Format

    • Manufacturing Information
    • Environmental Assessment
    • Color Additives (if applicable)
    • Individual Subject Report Forms
    • Patient Assessment
    • Demographic Data
    • Data Analysis Results
    • Device Failures and Replacements
  • Conclusions Drawn from Studies

    • Risk/Benefit Analysis
    • Safety
    • Effectiveness
  • PMA Post Market Requirements

    • General Requirements
    • Post approval (Annual) Reports
    • Adverse Reaction and Device Defect Reporting [814.82(a)(9)]
    • Medical Device Reporting (MDR)
    • Premarket Approval Application (PMA) Supplement