Digital health companies are playing an important role in the global response to the COVID-19 public health emergency. For example, the White House Office of Science and Technology Policy issued a Call to Action to the tech community requesting help in answering urgent scientific questions about COVID-19. As readers of
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FDA Issues Updated Guidance on the Regulation of Digital Health Technologies
On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ensure alignment with the new approaches being adopted by the Agency.
As background, FDA issued draft guidance documents in December 2017 that sought to implement section 520(o)(1) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), which was enacted by Congress in the 21st Century Cures Act of 2016 (the “Cures Act”). Those guidance documents raised a number of issues that we discussed on this previous alert.
After receiving comments from stakeholders, the Agency responded by issuing: (i) a revised draft guidance document for clinical decision support (CDS) software (“Clinical and Patient Decision Support Software” or the “CDS Draft Guidance”) and (ii) a final guidance document for other software functions exempted by the Cures Act (“Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act” or the “Software Policies Guidance”).
Here are key takeaways on FDA’s newly-issued guidance:
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Top 10 Questions During Ideation of Digital Health Solutions
Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions. “Ideation” is the part of that process and involves the rapid identification and creation of ideas for digital health solutions, which are then prototyped and tested. Covington has created a Top 10 Questions
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Significant FDA Digital Health Policy Development for Prescription Drug Sponsors
As previewed by Commissioner Gottlieb several months ago (see our earlier post here), FDA published a notice in the Federal Register on November 20, 2018, to propose a new framework for “prescription drug-use-related software.” The Agency defines this digital health category widely as software disseminated by a prescription drug sponsor for use with the sponsor’s prescription drug(s). Last spring, the Commissioner stated that FDA would be seeking input “on how to support the development of digital health tools that are included as part of approved drugs.” The goal in establishing the framework, Gottlieb stated, would be “to develop an efficient pathway for the review and approval of digital health tools as part of drug review, so that these tools reach their full potential to help us treat illness and disease, and encourage synergies between software and therapeutics that meet FDA’s gold standard for safety and effectiveness.”
This policy development is significant, not only because it is one of CDER’s first policy statements on digital health associated with pharmaceuticals (see a few of our earlier posts about pharma-related digital health here and here), but also because it implicates a broad range of information that could be made available by prescription drug sponsors through software used with their products. We encourage prescription drug sponsors with any interest in providing digital health solutions, including through collaborations, to review the Federal Register notice and consider submitting comments to FDA.
Here are a few key takeaways from FDA’s notice:
- Under the proposed framework, software with the same drug-related functionalities will be subject to different regulatory approaches by FDA, depending on the developer of the software. FDA will apply the proposed framework to prescription drug-user-related software developed by or on behalf of pharmaceutical manufacturers, and a different approach to drug-related software developed “independently” by third-party software developers and other entities that are not prescription drug sponsors.
- It is unclear from the notice how the proposed framework, including the evidentiary standards described in the Federal Register notice, will align with other FDA initiatives such as the use of real-world evidence for drug development and the pre-certification program (see our earlier post here).
- An important question for prescription drug sponsors in particular is whether the proposed framework will encourage continued digital health innovation, including through collaborations, or whether FDA’s proposal will create challenges that may discourage advances in this area.
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Inside FDA’s Latest Digital Health Developments: Gottlieb Sees “Vast Potential” Ahead
On April 26, Commissioner Gottlieb addressed the agency’s progress on FDA’s Digital Health Innovation Action Plan and announced several additional steps the agency is taking to advance the potential benefits of digital health. Here is a recap of the key updates:
(1) Launch of New FDA Program to Apply Digital
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Key Takeaways from Covington’s Webinar about Digital Health Associated with Pharmaceuticals
On February 1, 2018, Covington’s Digital Health team hosted a webinar examining U.S. and EU regulatory issues for digital health associated with pharmaceuticals. Here are some key takeaways from that webinar:
- Neela Paykel from Proteus Digital Health, noted that “you need to think outside the box for how to engage,
FDA Outlines Updated Approach to Regulating Digital Health Technologies
On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft guidances announce the agency’s initial interpretation of the health software provisions enacted as part of last year’s 21st Century Cures Act (the “Cures Act”).
Given the rapid pace of digital health innovation across the life sciences, technology and health care sectors, FDA guidance on these topics is critical. Here are a few key takeaways from the draft guidances:
- FDA’s initial interpretation of the Cures Act provision related to clinical decision support (CDS) software may lead to a fairly narrow carve-out—in other words, many cutting-edge CDS software functions could remain subject to FDA regulation.
- FDA’s draft guidances do not directly address dynamic digital health solutions, such as those that incorporate machine learning, artificial intelligence (AI), or blockchain.
- FDA has proposed an enforcement discretion approach for decision support software aimed at patients that generally parallels the regulatory approach for CDS software aimed at clinicians, even though patient decision software was not addressed directly in the Cures Act.
- Consistent with the Cures Act, FDA’s draft guidances reflect that many of the software functions that were previously subject to FDA enforcement discretion (i.e., not actively regulated as devices) no longer meet the definition of “device.”
- Significant for pharmaceutical companies, CDER joined one of the draft guidances, and that draft guidance makes clear that other FDA requirements may apply to digital health products disseminated by or on behalf of a drug sponsor beyond those outlined in the draft guidance.
FDA’s regulatory approach has a significant impact on the investment in and development of digital health solutions across the digital health ecosystem. Stakeholders should consider submitting comments to the agency to help shape the direction of FDA’s final guidances on these topics.Continue Reading FDA Outlines Updated Approach to Regulating Digital Health Technologies
The Evolving FDA and EU Equivalent Regulation of Digital Health: A Device Perspective
On November 14, lawyers from Teva Pharmaceuticals and Covington & Burling discussed digital health innovation from a medical device regulation perspective in the U.S. and the EU. The presentation by Rachel Turow, Executive Counsel – Regulatory Law, Teva Pharmaceuticals, and Grant Castle, Scott Danzis, Sarah Cowlishaw, and Christina Kuhn of
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FDA Initiates Software Precertification Pilot Program
On Friday, July 28, FDA announced a new Software Pre-certification (Pre-Cert) Pilot Program in a Federal Register notice. The Pre-Cert program is one of three main action items discussed in the agency’s recently-released Digital Health Innovation Action Plan. CDRH also held a webinar on August 1 to provide an overview of the program and answer stakeholder questions.
In an accompanying FDA Voice blog post, Commissioner Gottlieb acknowledged that “FDA’s traditional approach to medical devices is not well suited” to digital health products. The agency is looking to develop a new regulatory framework that “accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface, and industry’s compressed commercial cycle of new product introductions.”
The Pre-Cert pilot program is the agency’s first step in developing the Pre-Cert program that the agency initially announced last month. The Pre-Cert program will replace the agency’s current product-by-product premarket review process with a process to pre-certify software developers who demonstrate sufficient quality performance. Pre-certified developers would be able to market their software devices with no, or streamlined, premarket review. The program is intended to allow manufactures of software devices to get to market faster and have greater flexibility to iterate product design based on real world experience.
To move the Pre-Cert program from concept to implementation, the agency is initiating a pilot program. The goal of the pilot is to leverage input from the participating companies to help the agency establish the appropriate criteria for pre-certification and appropriate review process for pre-certified companies. Thus, participating companies will have a remarkable opportunity to shape the program and the agency’s regulatory approach to digital health products.
The Pre-Cert program’s developer-based approach represents a significant shift from the agency’s longstanding, fundamental approach to regulating medical products on a product or category basis regardless of the manufacturer. We expect that there will be significant interest in the pilot, although FDA will only select nine companies to participate. FDA also strongly encourages companies who do not participate in the pilot to submit feedback through the public docket.Continue Reading FDA Initiates Software Precertification Pilot Program
FDA Releases Details and Timelines in Its Digital Health Innovation Action Plan
On July 27, FDA published its Digital Health Innovation Action Plan. The plan provides details and timelines for the agency’s Digital Health Innovation Plan, announced by FDA Commissioner Scott Gottlieb last month.
The action plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation
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