FDA Draft Guidance Proposes to Exempt Certain Devices From 510(k) Requirements

The Food and Drug Administration July 7 issued a draft guidance describing its intent to exempt from the 510(k) premarket notification process certain in vitro diagnostic (IVD) and radiology devices with well-established safety and effectiveness profiles.

While FDA said it intends to exempt those devices from the 510(k) requirement through rulemaking that would reclassify the class II devices and amend the classification regulations of class I (lowest risk) devices, FDA said it no longer believes it is necessary to review 510(k) submissions for these devices before they enter the market.

According to the guidance, FDA intends to propose the down-classification ...