Recommended Steps to Decide the Regulatory Path for a Modified PMA Device
Step 1. Identify the modification and reason for it.
Step 2. Conduct a risk analysis.
Step 3. Define testing that will assess the impact of the modification on safety and effectiveness.
Step 4. Choose the regulatory pathway from the options below, see reference A below flowchart for additional
information regarding regulatory pathway choice. Multiple branches from Step 4 follow:
New clinical and new preclinical, lead to new original PMA. New clinical and potentially some new preclinical, lead to panel-track supplement. Preclinical and potentially limited confirmatory clinical, lead to 180-day supplement. Preclinical only, lead to real-time supplement. Manufacturing change affecting safety and effectiveness, lead to 30-day / 135-day supplement. Manufacturing site change supplement. Change or changes that enhance the safety of the device, lead to special supplement changes being effected. Change or changes that do not affect safety and effectiveness, lead to annual report.