In the United States, the U.S. FDA (Food and Drug Administration) provides medical device regulation through the CDRH (Center for Devices and Radiological Health). The agency recently released its proposed FDA medical device regulations for 2022 indicating a heavy focus on software as related to medical devices. Here’s a breakdown of the ones we think will be among the most important changes for our clients that they should be on the lookout for:
Clinical Decision Support Software
This final guidance for FDA medical device regulation seeks to clarify the FDA’s authority in overseeing clinical decision support (CDS) software used by health care providers, patients, or caregivers. CDS software provides information to support a clinician’s decisions regarding the diagnosis, treatment, prevention, cure, or mitigation of diseases or other health conditions. The FDA’s Safety and Innovation Act (FDASIA) Health IT Report of 2014, outlines CDS more specifically as “a variety of tools including, but not limited to: computerized alerts and reminders for providers and patients; clinical guidelines; condition-specific order sets; focused patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant reference information.” This guidance for FDA medical device regulation incorporates changes to the Food, Drug, and Cosmetic (FD&C) outlined in the 21st Century Cures Act (Cures Act), that excludes certain software functions from the agency’s previous definition of a medical device. It also resolves which CDS it does not plan to enforce FDA device regulation compliance, even if they meet the current definition of a device, based on the agency’s current understanding of risks of the devices. This would include, but not be limited to, premarket clearance and premarket approval requirements. It also outlines which CDS it will focus on for meeting medical device regulatory requirements.
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
While the agency has not yet released this draft guidance for FDA medical device regulation, it is a topic to keep an eye on. Medical devices are increasingly connected, and with that comes a greater risk for cybersecurity breaches, and greater scrutiny by the FDA prior to medical device approval. In addition to addressing FDA quality system regulation, the draft guidance will likely reevaluate its current guidance for the content of premarket submissions for management of cybersecurity in medical devices released in October of 2014.
Content of Premarket Submissions for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)
The FDA released its draft guidance related to premarket submissions for SaMD and SiMD in early November 2021. This has been an area of particular interest to the agency – they recently also created the FDA software precertification program, designed to give patients quicker access to SaMDs. This draft guidance for FDA medical device regulation outlines updated recommendations for documentation that should be included in premarket submissions to the agency. It covers:
- firmware and other means for software-based control of medical devices;
- stand-alone software applications;
- software intended to be operated on general-purpose computing platforms;
- dedicated hardware/software medical devices; and
- accessories to medical devices when those accessories contain or are composed of software
FDA Medical Device Regulation Goals
The FDA hopes the proposed recommendations will streamline both the organization and content included in a premarket submission, as well as provide additional guidance on the minimal amount of documentation that would be needed for a premarket submission for a medical device that utilizes software. Once finalized, this guidance will replace guidance published in May of 2005.
The FDA has broken down its list of guidance documents based on their priority to the agency. It is currently soliciting comments on the draft guidance for FDA medical device regulation, both on the proposals themselves as well as how the FDA has prioritized them.At Sterling Medical Devices, our medical device regulatory compliance consultants take on the burden of navigating FDA medical device regulation to help you meet the required regulatory controls that assure your medical device’s safety and effectiveness—throughout the entire product development lifecycle. If we can help you, please contact us today.
