The FDA publishes guidance for pre-market notification submissions for pulse and blood oxygen level monitors.
The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices.
In the guidance, published March 4, the FDA specified new rules for identifying, testing and assuring safety for the systems. The new document overrides the 1992 guidance on the same category. The FDA's goal is to help device companies prepare their premarket notifications, or 510(k)s, for any pulse oximeter.