FDA Commissioner Announces New Digital Health Policies
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The US Food and Drug Administration (FDA) has released three new digital health policy documents to outline the FDA’s approach in the development and oversight of digital health tools.

FDA Commissioner Scott Gottlieb issued a statement explaining the new policies. “We know that consumers and healthcare providers are increasingly embracing digital health technologies to inform everyday decisions,” Gottlieb said. “…Therefore, our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation.”

Gottlieb says over the last five years, the FDA has found that in some parts of its regulatory portfolio, its traditional approach to overseeing certain healthcare products does not easily fit the types of innovations that are being developed. In these cases, Gottlieb says the FDA must adapt and evolve its policies.

To this aim, in the summer of 2017, the FDA issued the Digital Health Innovation Action Plan, which involved several key goals, including increasing the number and expertise of digital health staff at the FDA, launching the digital health software precertification pilot program (“Pre-Cert”), and issuing guidance to modernize the agency’s policies. Thus far, the FDA has launched the Pre-Cert pilot and selected nine companies to participate.

The three new guidances – two draft and one final – address, in part, provisions of the 21st Century Cures Act (“Cures Act”), which is designed to help accelerate medical product development and offer additional clarity about where the FDA sees its role in digital health, and where it doesn’t see a need for FDA involvement. The FDA says it has taken the instructions Congress gave it under the Cures Act and are building on the provisions.

The first draft guidance, Clinical and Patient Decision Support Software, outlines the FDA’s approach to clinical decision support software (CDS). “CDS has many uses, including helping providers, and ultimately patients, identify the most appropriate treatment plan for their disease or condition,” Gottlieb said in his statement. “For example, such software can include programs that compare patient-specific signs, symptoms or results with available clinical guidelines to recommend diagnostic tests, investigations or therapy. This type of technology has the potential to enable providers and patients to fully leverage digital tools to improve decision-making. We want to encourage developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating old and new medical maladies.”

This draft guidance is provided to make clear what types of CDS would no longer be defined as a medical device, and thus would not be regulated by the agency. For example, generally, the FDA says CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation.

However, the FDA says it will continue to enforce oversight of software programs that are intended to process or analyze medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as these remain medical devices under the Cures Act. 

Similarly, the CDS draft guidance also proposes to not enforce regulatory requirements for lower-risk decision support software that is intended to be used by patients or caregivers — known as patient decision support software (PDS) — when such software allows a patient or a caregiver to independently review the basis of the treatment recommendation. Although PDS was not part of the Cures Act, the FDA says it believes that PDS should follow a similar regulatory structure as CDS. An example of lower-risk PDS products could include software that reminds a patient how or when to take a prescribed drug, consistent with the drug’s labeling.

The second draft guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, outlines the FDA’s interpretation of the types of software that are no longer considered medical devices.

“Through this draft guidance, we’re proposing changes to previously published agency guidance documents, including: General Wellness and Mobile Medical Applications, among others, to be consistent with the Cures Act and reflective of the agency’s new, more modern approach to digital health products,” Gottlieb said in his statement. “The proposed changes include updating the categories of products for which, prior to the Cures Act, the FDA already intended to exercise enforcement discretion owing to their very low risk and potential benefits to patients from greater innovation. Now, to create an even clearer distinction, consistent with the Cures Act, we’re saying that many of these products no longer qualify as medical devices that would be subject to the FDA’s oversight.”

The FDA says it is also working with its global counterparts to streamline the regulation of digital health products internationally. The agency says it has worked with regulatory authorities internationally through the International Medical Device Regulators Forum to evaluate requirements in individual countries and harmonize regulatory approaches to digital health medical devices, where possible. Some of the global counterparts include: Australia, Brazil, Canada, China, the European Union, Japan, Russia, and Singapore.

As part of the package of policies announced, the FDA has also issued final guidance, Software as a Medical Device: Clinical Evaluation, in fulfillment of international harmonization efforts. This guidance was initially issued in draft in October 2016 and was informed by global and domestic comments. The final guidance expands on that draft. The FDA says it establishes common principles for regulators to use in evaluating the safety, effectiveness, and performance of Software as a Medical Device (SaMD). The final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product.

As part of implementing the FDA’s Digital Health Innovation Action Plan, the agency is hosting a Pre-Cert Pilot Program workshop on January 30-31, 2018 to update FDA staff, participants, and stakeholders on the lessons learned from the pilot. Later in 2018, the FDA says it will share the pilot’s proof of concept and outline next steps for establishing a Pre-Certification Program.

Source: FDA (Commissioner’s statement), FDA (CDS guidance), FDA (policies resulting from Cares Act), and FDA (final guidance)

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