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# BD Delays Alaris Modifications 510(k) by 6 Months
- URL: https://www.fdaweb.com/bd-delays-alaris-modifications-510-k-by-6-months/
- Published: 2020-08-10T12:00:00.000Z
- Updated: 2026-09-14T16:24:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147395

Becton Dickinson (BD) is predicting a six-month delay in submitting a 510(k) for modifications to its troubled Alaris infusion pump. On a recent earnings call, BD president **Tom Polen** told analysts that the 510(k) should be filed in late March of 2021, which is about six months later than the company predicted in May.

The device, which the company says is used on about 70% of patients undergoing infusion therapy, has been hampered by a recent [cybersecurity threat](http://fdaweb.com/login.php?sa=v&aid=D5144346&searchWords=alaris&cate=S&stid=%241%243N2.O40.%24DuPi8c3%2F5qM70xjbqmS3d1&ref=fdaweb.com) and a recall of its [bezel assembly](http://fdaweb.com/login.php?sa=v&aid=D5144585&searchWords=alaris&cate=S&stid=%241%243N2.O40.%24DuPi8c3%2F5qM70xjbqmS3d1&ref=fdaweb.com) because of a defect that could result in free flow, over-infusion, under-infusion, or interruption of infusion. The company earlier said it was caught off-guard and had not believed the device modifications were going to require a 510(k) submission.

“In our pre-submission conversations, the focus has been on having a complete and robust submission and we have been spending additional time on aligning the testing protocols upfront, which is time and effort well spent,” Polen is quoted as saying in an [earnings transcript](https://seekingalpha.com/article/4365530-becton-dickinson-and-company-bdx-ceo-tom-polen-on-q3-2020-results-earnings-call-transcript?part=single&ref=fdaweb.com). “We believe the more work we do upfront to ensure the most robust submission, the better we are enabling a timely review and clearance process... When it comes to human factor testing, we've completed 100% of our formative testing which is a significant milestone involving 12 different human factor tests in the middle of the pandemic. We are pleased with the data and outcomes. We have also completed a substantial software system verification. Completion of formative human factor testing and software verification retires significant risk to the submission.”

Polen said the delay is needed to “ensure full alignment with the FDA on the final phase of human factor testing which is referred to as a summative testing. And again we feel this investment in time now best serves us in meeting our ultimate goal of a timely 510(k) clearance. We have submitted our summative testing protocols to the FDA and expect feedback shortly.”

In addition, Polen said as part of BD’s ongoing feedback discussions with the agency the company has decided to include an update to its specialty EtCO2 module, which is used to help monitor patients on ventilators while a medication is being administered. “We believe this is the right decision for the Alaris system over the long term and the patients we serve, and far outweighs the additional time line of a few weeks it takes to include it again providing the most comprehensive submission to the FDA to help enable a timely review and clearance,” he said.