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Through more than a decade of experience in private practice and positions within the FDA and on the Hill, Wade Ackerman has acquired unique insights into the evolving legal and regulatory landscape facing companies marketing FDA-regulated products. Mr. Ackerman advises clients on FDA regulatory matters across a range of sectors, including drugs and biologics, cosmetics, medical devices and diagnostics, and digital health products and services associated with drugs and traditional devices. He serves as one of the leaders of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and marketing of digital health technologies.

On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software.

The concept of “multiple function” products was introduced by the 21st Century Cures Act (“Cures Act”) of 2016, which

The following guidance could be relevant to manufacturers of software as a medical device (SaMD).  The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of an interruption or permanent discontinuance

On April 14, 2020, FDA issued a direct-to-final guidance outlining its “Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”  The guidance intends to “expand the availability of digital health therapeutic devices” – possibly the first time FDA has used such term in its written policies – to facilitate consumer and patient use and reduce potential exposure to COVID-19.  The guidance applies to two groups of products: (1) computerized behavioral therapy devices and other digital health devices for psychiatric disorders; and (2) low-risk wellness and digital health products for mental health or psychiatric conditions. Like FDA’s many other COVID-19 enforcement policies, the policy will remain in effect “only for the duration of the public health emergency related to COVID-19.”
Continue Reading FDA Issues COVID-19 Policy for Certain Digital Health Solutions

The COVID-19 crisis is demonstrating the potential of digital health technology to manage some of our greatest public health challenges.  The White House Office of Science and Technology Policy has issued a call to action for technology companies to help the science community answer high-priority scientific questions related to COVID-19.  The Centers for Disease Control

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:
Continue Reading FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

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

Last week, Senators Amy Klobuchar (D-MN) and Lisa Murkowski (R-AK) introduced the Protecting Personal Health Data Act (S. 1842), which would provide new privacy and security rules from the Department of Health and Human Services (“HHS”) for technologies that collect personal health data, such as wearable fitness trackers, social-media sites focused on 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.

According