The U.S. Food and Drug Administration (FDA) has issued a suite of new guidances aimed to encourage innovative approaches to the development of digital health tools—including fresh guidance around clinical decision support software.
The FDA, an agency within the U.S. Department of Health and Human Services, also wants to ensure that its internal approach to overseeing these technologies advances along with the development of digital health tools, according to a statement from the federal agency.
FDA officials noted that digital health technologies— such as tools that more easily report blood glucose levels to smart watches that can detect atrial fibrillation—are increasingly being embraced by patients and thus have the ability to help them make better and more efficient decisions about the healthcare.
Broadly, the FDA believes that “an appropriate regulatory framework that takes into account the realities of how technology advances plays a crucial role in the efficient development of digital health technologies.” Since the agency issued its Digital Health Innovation Action Plan in 2017, the FDA attests its “approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation.”
As part of that plan, the FDA says it has accomplished several key initiatives, including launching and testing the digital health software precertification pilot program (“Pre-Cert”) and taking steps to modernize its policies.
Now, the new guidances issued aim to continue those efforts announced as part of the Digital Health Innovation Action Plan and address key provisions of the 21st Century Cures Act, that offer additional clarity about where the FDA sees its role in advancing safe and effective digital health technologies, officials noted. “We’ve taken the goals we were entrusted with by Congress under the Cures Act and are building on these provisions to make sure that we’re adopting the full spirit of the intent to provide a practical oversight framework that is risk based,” they said.
The first guidance, Clinical Decision Support Software, is a revised draft guidance based on careful review of public comments received on the previous draft published in 2017, according to the agency. Clinical decision support (CDS) software—intended to inform the physician’s clinical management of their patients—" has enormous potential to improve clinical decision making. We want to encourage developers to create, adapt and expand the functionalities of their software to support providers in diagnosing and treating diseases, while also ensuring the software doesn’t introduce unacceptable risk to the patient,” FDA officials stated.
Following the FDA’s original draft guidance on CDS in 2017, the agency received feedback from many stakeholders, suggesting improvements that could be made to better clarify the agency’s oversight of CDS products. More specifically, stakeholders asked that the FDA consider the inclusion of risk-based categorization of software products based on the risk to patients if a software product malfunctions.
As such, the FDA has leveraged the International Medical Device Regulators ForumExternal Link Disclaimer (IMDRF) risk-based framework for categorizing products. The IMDRF final document, “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding ConsiderationsExternal Link Disclaimer,” establishes common principles that can be used by all stakeholders, including regulators, to promote safe innovation and protect patient safety, FDA officials noted.
“The draft guidance clarifies categories of CDS that would be subject to FDA oversight, categories of CDS for which we intend not to enforce applicable regulatory requirements (known as enforcement discretion) due to the software’s low risk to patients, and CDS categories that do not meet the definition of a medical device,” they added.
According to officials, “In this draft guidance, we propose to focus our regulatory oversight on CDS functions that are intended to help healthcare professionals and patients inform their clinical management for serious or critical conditions and that are not intended for healthcare professionals to independently evaluate the basis of the software’s recommendations.”
An example of a product that the FDA said it focus its oversight on would be CDS that identifies hospitalized, type 1 diabetic patients at increased risk of postoperative cardiovascular events and which does not explain why the software made that identification to the healthcare professional. “In this case, if the CDS provides information that is not accurate (e.g., inappropriately identifies a patient as low risk when he is high risk), then any misidentification could lead to inappropriate treatment and patient harm. Since the potential for patient harm is significant, FDA regulation plays an important role in evaluating the software’s safety and effectiveness,” officials explained.
The FDA believes its “proposed approach for regulating CDS not only fulfills the provisions of the Cures Act, but also strikes the right balance between ensuring patient safety and promoting innovation by clarifying which products would be the focus of FDA’s oversight and which would not.”
The FDA has also updated four previously issued FDA final guidances to align with interpretations and policies under the Cures Act: Final Guidance on Policy for Device Software Functions and Mobile Medical Applications; Final Guidance on General Wellness: Policy for Low Risk Devices; Final Guidance on Off-The-Shelf Software Use in Medical Devices; Final Guidance on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.
