📢 Before marketing a medical device in the U.S., it's important to know how the FDA classifies it.
Class I – Low Risk
✅ Minimal potential harm
📋 Basic regulatory controls apply
📌 Examples: Bandages, Tongue Depressors
📝 FDA Submission: 510(k) or Exempt
⚠️ Higher risk than Class I
🔬 Requires additional regulatory controls
📌 Examples: Infusion Pumps, Diagnostic Ultrasound
📝 FDA Submission: 510(k) (Some exemptions apply)
Class II – Moderate Risk
🚨 Sustains/supports life or has high risk
🧑⚕️ Strict regulatory requirements apply
📌 Examples: Pacemakers, Heart Valves
📝 FDA Submission: PMA (Pre-Market Approval)