FDA Labels Magnetic Surgical Instrument Systems as Class II

The FDA issued a final order that classified magnetic surgical instrument systems as Class II devices with special controls.

Firms that intend to market this type of device must submit a premarket notification and comply with the special controls listed in the final order.

A magnetic surgical instrument system is used in laparoscopic surgical procedures and consists of several components, including surgical instruments and a magnetic controller. — Tamra Sami