FDA 510(k) Exempt Devices

Many Class I medical devices are exempt from 510(k) premarket notification. LMG explains which devices are 510(k) exempt and what requirements still apply.

Liberty Management GroupClass I DeviceSince 2009

FDA Device Classification

Many Class I medical devices and some Class II devices are exempt from 510(k) premarket notification requirements. However, 510(k) exemption does not mean exempt from all FDA requirements.

510(k) exempt devices must still: register the medical device establishment with FDA, list the device with FDA, comply with applicable device-specific special controls, and comply with General Controls under 21 CFR Part 820.

Common examples of 510(k) exempt Class I devices include: tooth brush, sunglasses, Dental floss, Manual stethoscope, bedpan, tongue depressors, elastic bandages, and many surgical instruments. Check the FDA device classification database to determine if your device is 510(k) exempt.

LMG assists manufacturers in determining whether their device requires 510(k) clearance or qualifies for a 510(k) exemption.