The FDA posted a mid-year update for the precertification program for software as a medical device, stating that the retrospective testing of the excellence appraisal and the streamlined review components has been successfully completed. FDA reviewers indicated that the regulatory decisions can be made using these segments of the pre-cert system, but recommended that the elements of these modules be presented in a structured format for prospective testing. The results include that these portions of the pre-cert program are sufficient to conduct a premarket review of software as a medical device. The pre-cert working model 1.0 was based on the assumption that the excellence appraisals would run on average to five business days, but the process has typically been completed in three to four days during prospective testing, and among the next steps is to determine whether the pre-cert pathway will align with the results of traditional premarket pathways.
The FDA said the class I recall of Alaris infusion sets for the Alaris 8100 infusion pump by Becton, Dickinson and Co. (BD), of Franklin Lakes, N.J., is due to the risk of over-delivery of the drug of infusion while the pump is not in "running status" mode due to non-uniform thickness of the silicone segment of the sets. The recall of the Alaris pump model 8100 infusion sets affects more than 151 million sets distributed in the U.S. between July 1, 2016, and April 18, 2019, and several of the reports have been associated with patient injury, although the agency did not state that any fatalities were due to the problem. The separate recall of the BD/Carefusion model 8100 bezel assembly was initially undertaken in August 2017, but has been expanded to all 8100 model bezels distributed between April 2011 and June 2017. The total number of devices in the 8100 bezel recall is more than 586,000, and is due to cracked and separated bezels that could lead to inaccurate delivery of fluids to patients. Analysts with Wells Fargo Inc., of San Francisco, said it is not clear whether BD has identified the root cause of the issues with the devices, and whether the FDA is satisfied with the company's remediation plan. BD currently enjoys a market share of roughly 50%, the Fargo note stated, adding that the sponsor may attempt to expedite the development of its next generation infusion pump. Baxter Healthcare, of Deerfield, Ill., may benefit from BD's difficulties, and Fargo said BD will likely address the matter in a third-quarter report scheduled for Aug. 6.