📜CPSC Final Rule on Electronic Filing of Compliance Certificates
In consultation with U.S. Customs and Border Protection (CBP), the U.S. Consumer Product Safety Commission (Commission or CPSC) issues this final rule (the Final Rule) to revise the agency's regulation for Certificates of Compliance (certificates). The Final Rule aligns CPSC's current certificates rule with other CPSC rules on testing and certification, and implements, for importation of products and substances regulated by CPSC, electronic filing of certificates (eFiling) with CBP.
Learn More🩺FDA Draft Guidance on Pulse Oximeters for Regulatory Compliance
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Pulse Oximeters for Medical Purposes--Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations." This draft guidance document, when finalized, will provide recommendations regarding non-clinical and clinical performance testing of certain pulse oximeters for medical purposes, including devices with a pulse oximeter function that estimates the amount of oxygen in arterial blood and pulse rate. These recommendations are being proposed based in part on concerns that the accuracy of pulse oximeters can be affected by, among other factors, a person's skin pigmentation. The recommendations are being proposed to inform the performance evaluation for these devices, to support premarket submissions, regardless of submission type, and to promote consistency and facilitate efficient review of these submissions. Among other topics, the draft guidance also proposes recommendations for labeling, which are intended to promote the safe and effective use of pulse oximeters and help users understand the benefits and risks associated with the use of the device. This draft guidance is not final nor is it for implementation at this time.
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