FDA Releases Final Clinical Decision Support Software Guidance and Plans to Address Bias in Pulse Oximeters
FDA has published final guidance on determining whether clinical decision support software is considered a medical device. The final text diverges significantly from the draft released in 2019, omitting sections on the International Medical Device Regulators Forum’s (IMDRF) risk categorization, and completely rewriting other parts of the document. The result is a 26-page final guidance that is focused on how the FDA interprets legislation on software functions that do not meet the definition of a device, supported by examples.
The FDA has decided to intervene amidst increasing evidence that pulse oximeters are providing erroneous results for patients with darker skin tones. As a result, the FDA has organized a virtual meeting to further examine the racial bias of the aforementioned devices. Pulse oximeter clinical studies mostly involve people of Caucasian race which is the primary reason behind the ineffectiveness on people of color. This issue with pulse oximeters has been critical during the pandemic considering health care professionals are using these devices to triage and monitor oxygen levels of patients.
The FDA announced it has issued a draft guidance on software assurance in relation to medical device production. The Agency stated multiple reasons for the issuance including giving industry professionals a baseline on how to evaluate computer software used for production or quality systems using a risk-based approach and giving appropriate stakeholders a means on how to validate the software. The draft guidance is associated with the “General Principle of Software Validation” guidance which was published in January 2002. Ultimately, this computer software risk-based approach will help fulfill the conditions of 21 CFR 820.70 (i), which revolves around automated processes as part of production or quality system.
The FDA finalized its guidance for “Electronic Submission Template for Medical Device 510(k) Submissions” that states medical device manufacturers will need to utilize the Agency’s electronic Submission Template and Resource (eStar) starting October 1st, 2023. Moreover, the types of submissions that fall under this guidance include Traditional, Special, and Abbreviated 510(k)s as well as supplements and amendments. The FDA explains the advantages of using the eStar template as a means to collect and assemble 510(k) submission content similar to the 510(k) review memo template applied by CDRH submission reviewers.
The insufficient assessment of medical device cybersecurity by the FDA may be associated with a lack of funding and ill-equipped personnel within the Agency. To aid the issue, the FDA has requested $5.5 million in funding for 2023 to improve the medical device cybersecurity program through the hiring of appropriate staff in the associated fields. Even with the funding request, experts believe the FDA will be well short of its goals to improve on comprehensive cybersecurity assessments.
(In Compliance 9/9/22)
The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, RAC, Simbex Senior Quality Assurance/Regulatory Engineer, Amit Guruprasad, Simbex Quality Engineer, and Angela Smalley, PhD, Simbex Senior Commercialization Consultant. A story’s inclusion does not imply endorsement by Simbex.