chevron-down Created with Sketch Beta.
March 31, 2023

Eracent to Provide SBOM Management Application to Any HCP

The FDA had updated the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook in November 2022 and included a recommendation that healthcare delivery organizations request a Software Bill of Materials (SBoM) from medical device manufacturers. The SBoM is a standardized listing of all software components that may be included in a medical device and can both help mitigate damage caused by cybersecurity intrusions and help in analysis by scanning for vulnerabilities. On December 29, 2022, the Consolidated Appropriations Act, 2023 became law and added a new section 524B to the Federal Food, Drug, and Cosmetic Act.  Section 524B requires all medical device manufacturers or sponsors to submit a Software Bill of Materials (SBoM) with their applications for all future premarket devices.This new requirement went into effect on March 29, 2023.  The FDA issued a notice that it intends not to summarily reject premarket applications submitted before October 1, 2023 if they fail to comply with the cyber requirements, but instead work with the manufacturers/sponsors of the submissions during this transition period. This week, Eracent, an asset management company, announced that they would offer medical providers, as well as medical device manufacturers, free access to their Supply Chain Risk Management solutions to help satisfy these FDA requirements. 

The material in all ABA publications is copyrighted and may be reprinted by permission only. Request reprint permission here.