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.
A pulse oximeter is any device that uses radiation wavelengths through skin and blood to determine pulse and blood oxygen levels, sometimes with a fiberoptic catheter.
The federal watchdog agency recommended that companies identify their devices with a regulation number and product code. The company should also include the specific intended use for the device and the basic device design, including drawings and a thorough comparison to other similar devices on the market.
In regards to testing, the FDA document says that companies must test for accuracy, must conduct equivalent performance in group testing and must report wether the test incorporates original equipment manufacturer cleared technology. If the company modifies the device significantly, it will have to submit a new 510(k). "Significant" modifications include electrical sensor modifications or changes to the algorithms in the software.
Additionally, the document includes rules for biocompatibility (testing the toxicity of materials in the device that will be exposed to the skin) and sterilization procedures.
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