A Complete Guide to Classifying Your Medical Device for FDA Approval

A team of surgeons performs a delicate procedure in a technologically advanced operating room, surrounded by monitors and medical equipment, ensuring precision and care.

The FDA classifies medical devices into Class I (low risk), Class II (moderate risk), and Class III (high risk), each with its regulatory controls and approval pathways. Class I devices typically face minimal oversight and may be exempt from premarket submission, while Class II devices generally require 510(k) clearance to prove substantial equivalence to existing products. Class III devices, which pose the highest risk, must undergo the rigorous Premarket Approval (PMA) process supported by extensive safety and efficacy data.

Manufacturers can determine classification by researching similar products in the FDA’s Product Classification Database and selecting an appropriate regulatory pathway—510(k), PMA, De Novo, or exemption. Early classification helps avoid costly delays and ensures smoother approval. Consulting regulatory specialists is also recommended to verify compliance, streamline documentation, and support a successful submission to efficiently bring the device to market.