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To Market, To Market: FDA’s Digital Health Precertification Program

In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software applications and other transformative technologies, such as artificial intelligence and 3D printing, are reshaping how medical devices are developed, and FDA is seeking to align its mission and regulatory obligations with those changes. FDA’s digital health software precertification program is a prime example of this approach. Once fully implemented, this voluntary program should expedite the path to market for software as a medical device (SaMD), and promote greater transparency between FDA and regulated entities. Under the program, FDA will conduct a holistic review of the company producing the SaMD, taking into account aspects such as management culture, quality systems and cybersecurity protocols, to ascertain whether the company has developed...

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FDA’s Breakthrough Device Program: Opportunities and Challenges for Device Developers

As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. In December 2018, FDA issued a guidance document describing policies FDA intends to use to implement the Program. There are two criteria for inclusion in the Breakthrough Device Program: The device must provide for a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition; and The device must (i) represent breakthrough technology, (ii) have no approved or cleared alternatives, (iii) offer significant advantages over existing approved or cleared alternatives, or (iv) demonstrate that its availability is in the best interest of patients....

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‘Patterns’ in Opioid Crisis: DEA to Examine Prescription Drug Data

On January 30, Attorney General Jeff Sessions announced a surge of Drug Enforcement Administration (DEA) agents and investigators over the coming month and a half, focused on pharmacies and prescribers who are dispensing unusual or disproportionate amounts of opioid drugs. The DEA will examine distribution and inventory data reported to the DEA by prescription drug manufacturers and distributors for "patterns" and "outliers" for further investigation. Read the full On the Subject.

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On the Digital Health Frontier: Developments Driving Industry Change in 2018

As digital health innovation continues to move at light speed, both new and incumbent stakeholders find themselves on a new frontier—one that challenges traditional health care delivery and payment frameworks, in addition to changing the landscape for product research, development and commercialization. Modernization of the existing legal framework has not kept pace with the rate of digital health innovation, leaving no shortage of obstacles, misalignment and ambiguity for those in the wake. What did we learn in 2017 and what’s to come on the digital health frontier in the year ahead? From advances and investments in artificial intelligence (AI) and machine learning (ML) to the increasingly complex conversion of health care innovation and policy, McDermott’s Digital Health Year in Review details the key developments that shaped digital health in 2017, along with planning considerations and predictions for the health care and life science industries in 2018. ...

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Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018

Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment as well as product research, development and commercialization for both long-standing and new stakeholders. At the same time, lawmakers and regulators made meaningful progress toward modernizing the existing legal framework in a way that will both adequately protect patients and consumers and support and encourage continued innovation, but their efforts have not kept pace with what has become the light speed of innovation. As a result, some obstacles, misalignment and ambiguity remain. We are pleased to bring you this review of key developments that shaped digital health in 2017, along with planning considerations and predictions for the digital health frontier in the year ahead. Read the full Special Report.

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FDA Outlines the New Digital Health Innovation Action Plan and Software Precertification Pilot Program

Last Tuesday afternoon, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory approach toward moderate and high risk medical devices is not well suited for the fast-paced, iterative design, development and type of validation used for digital health software products today. Going forward, the agency plans to explore an innovative approach to regulating these types of products. The approach contains three primary prongs: (1) the issuance of new guidance, (2) the Digital Health Software Precertification Program and (3) an internal expansion of FDA’s digital health capabilities. The webinar was presented by Bakul Patel, Associate Director for Digital Health at FDA. At least 905 attendees logged in to the webinar. Below are a few important takeaways. The presentation provided a high-level overview of the digital health...

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Guidance on Low Risk General Wellness Devices Is Finalized

On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory requirements for low risk products that promote a healthy lifestyle—coined “general wellness products.” In the Final Guidance, the FDA makes minimal substantive changes to the policies articulated in its January 2015 draft guidance. Notably, however, the Final Guidance added and refined several examples to illustrate the products that are subject to FDA’s enforcement discretion and ultimately outside FDA’s intended scope of regulatory oversight. Read the full article, FDA Finalizes Guidance on Low Risk General Wellness Devices here.

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FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness

At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel infrastructure to conduct post-market effectiveness studies. Sentinel is an electronic surveillance system that aggregates data from electronic medical records, claims and registries that voluntarily participate and allows the agency to track the safety of marketed drugs, biologics and medical devices. As of August 2015, the Sentinel database includes information from 193 million individuals, 4.8 billion instances of prescription dispensing, 5.5 billion unique encounters and 51 million acute inpatient stays. The FDA currently uses the system to assess post-market safety issues. However, in a February 3, 2016, workshop, Dr. Woodcock announced that the FDA is in the early stages of adapting the Sentinel infrastructure to develop the “Guardian” system,...

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