The Medical Devices Introductory Course 2020

Classification

Risk-based classification based on historical precedence and defined product groupings and types (defined by medical / surgical specialty, listed in 21 CFR 862-892) • Class I (lower risk / control)

• Class II (medium risk / control) • Class III (higher risk / control) • Unclassified

High

High

Product Risk Class

Level of Regulatory Control

Medium

Medium

Low

Low

Submission Route

• “ Exempt ”

Submission Route

(no submission)

• “Premarket Notification” or “ 510(k) ” (submission for pre-market clearance)

• “ De novo ” (petition for reclassification)

• Premarket Approval (PMA) (pre-market submission for approval)

• Humanitarian Device Exemption (HDE) (submission for orphan use)