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 for Ideation of Digital Health

Today, FDA published a notice in the Federal Register announcing a public workshop on July 11-12 entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.”  This workshop builds on FDA’s ongoing efforts to implement the Real-World Evidence (RWE) Framework published in December 2018, which we previously discussed in this post.

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On December 7, FDA published the much-anticipated “Framework for FDA’s Real-World Evidence Program” for drugs and biological products (the “Framework”).  In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using real-world data (“RWD”) and real-world evidence (“RWE”) to enhance regulatory decision-making and noted that leveraging this information is “a top strategic priority for the FDA.”  FDA opened a docket for public comments on the Framework through February 5, 2019.

The Framework focuses in particular on the use of RWE to support regulatory decisions about effectiveness.  The agency outlines three considerations that will guide its overall RWE Program and inform the agency’s assessment of individual drug applications.  The Framework also offers background on the agency’s previous use and current initiatives with respect to RWE and related topics, such as innovative clinical trial designs.  This blog post provides an overview of FDA’s proposal and highlights a few initial takeaways noted by Covington’s Digital Health team.

Continue Reading Key Takeaways from FDA’s Framework for Real-World Evidence for 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, whether you’re a pharma company

On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From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

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 Covington, covered topics such as

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