Archives: Medical Devices and FDA

Subscribe to Medical Devices and FDA RSS Feed

Ideation Question #8: What is Novel in the Digital Health Solution and What Will Give the Solution a Competitive Advantage?

By Jessica Parezo and Joshua Gray on Posted in Data Security, Digital Health, Health Data, Medical Apps, Medical Devices and FDA
This is the eighth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process.  Today’s video explores the question: what is novel in the digital health solution and what will give the solution a competitive advantage?… Continue Reading

Ideation Question #7: Are Healthcare Providers Involved, and What Questions Should Be Considered for Collaborations?

By Sarah Franklin on Posted in Data Security, Digital Health, Health Data, Medical Apps, Medical Devices and FDA
This is the seventh of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process.  Today’s video explores the question: are healthcare providers involved, and what questions should be considered for collaborations?… Continue Reading

FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

By Elizabeth Guo, Christina Kuhn, Wade Ackerman and Scott Danzis on Posted in Artificial Intelligence (AI), Digital Health, Medical Apps, Medical Devices and FDA, Software
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 … Continue Reading

Top 10 Questions During Ideation of Digital Health Solutions

By Christina Kuhn, Wade Ackerman and Sarah Cowlishaw on Posted in Data Security, Health Data, Medical Apps, Medical Devices and FDA
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 … Continue Reading

FDA Outlines Proposed Framework for Regulating Artificial Intelligence Software

By Elizabeth Guo, Scott Danzis, Wade Ackerman and Lindsey Tonsager on Posted in Artificial Intelligence (AI), Innovation, Medical Apps, Medical Devices and FDA, Software
On April 2, 2019, FDA released a discussion paper entitled “Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)” (the “AI Framework”). The AI Framework is the Agency’s first policy document describing a potential regulatory approach for medical devices that use artificial intelligence (“AI”) and machine learning (“ML”). The … Continue Reading

NMPA Releases Draft Good Manufacturing Practice Appendix on Standalone Software

By Christopher Chen and John Balzano on Posted in China, Data Security, Medical Devices and FDA, Software
On January 3, 2019, the National Medical Products Administration (“NMPA”) published a draft standalone software appendix of medical device good manufacturing practice (“Draft Standalone Software GMP” or “Draft Appendix”) for public comment (available here).  Comments are due on January 30, 2019. China revised its medical device GMP in 2014, which apply to all classes of … Continue Reading

Significant FDA Digital Health Policy Development for Prescription Drug Sponsors

By Mingham Ji, Christina Kuhn, Elizabeth Guo, Wade Ackerman and Krista Carver on Posted in Artificial Intelligence (AI), Medical Apps, Medical Devices and FDA
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 … Continue Reading

AI Update: Medical Software and Preemption

By Robert Jacques and Emily Ullman on Posted in Artificial Intelligence (AI), Medical Devices and FDA
In light of the rapidly expanding field of medical software technology, and its recognition that traditional approval mechanisms for hardware-based medical devices may not be well suited to regulating such technology, FDA is piloting a new, streamlined regulatory approach for digital health technologies. The initiative, currently a “working model” and known as the Software Precertification … Continue Reading

Inside FDA’s Latest Digital Health Developments: Gottlieb Sees “Vast Potential” Ahead

By Christina Kuhn and Covington Digital Health Team on Posted in Artificial Intelligence (AI), Medical Apps, Medical Devices and FDA
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 Health to Drugs As our … Continue Reading

Latest NIST Draft Report a Call to Action for Federal Agencies and Private Companies

By Priscilla Fasoro and Covington Digital Health Team on Posted in Cybersecurity, Government Contracting, Internet of Things (IoT), Medical Apps, Medical Devices and FDA
Inflection Point for IoT In a relatively short amount of time, the adoption of the Internet of Things (IoT) and its applications— from smart cars to the myriad of interconnected sensors in the General Service Administration building reminiscent of HAL 9000 from 2001: A Space Odyssey— has rapidly proliferated, providing significant opportunities and benefits. However, … Continue Reading

Key Takeaways from Covington’s Webinar about Digital Health Associated with Pharmaceuticals

By Grant Castle, Sarah Cowlishaw, Wade Ackerman, Christina Kuhn and Covington Digital Health Team on Posted in Emerging Companies, Medical Apps, Medical Devices and FDA
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 … Continue Reading

FDA Outlines Updated Approach to Regulating Digital Health Technologies

By Christina Kuhn, Wade Ackerman, Scott Danzis and Covington Digital Health Team on Posted in Artificial Intelligence (AI), Medical Apps, Medical Devices and FDA
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 … Continue Reading

The Evolving FDA and EU Equivalent Regulation of Digital Health: A Device Perspective

By Grant Castle, Sarah Cowlishaw, Scott Danzis and Christina Kuhn on Posted in Medical Devices and FDA
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 … Continue Reading

Pharmaceutical Digital Health Innovators Take Note: FDA Public Hearing on an Innovative Approach to Devices Referencing Drugs

By Elizabeth Guo and Wade Ackerman on Posted in Health Data, Medical Apps, Medical Devices and FDA
On November 16, 2017, the Food and Drug Administration (“FDA” or the “Agency”) will hold a public hearing on a proposed approach for sponsors seeking to market devices referencing drugs (“DRDs”) when the drug sponsor does not wish to collaborate with the sponsor of the device. FDA will accept comments to the docket until January … Continue Reading

Digital Health Checkup (Part Two): Key Commercial Questions When Contracting for Digital Health Solutions

By Covington Digital Health Team, Wade Ackerman, Nigel Howard, Daniel Pavin and Lindsey Tonsager on Posted in Big Data, Cybersecurity, Data Security, Emerging Companies, Medical Devices and FDA, Personalized Medicine, Transactions
In the second of a three-part series, Covington’s global cross-practice Digital Health team considers some additional key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. Key Commercial Questions When Contracting for Digital … Continue Reading

Digital Health Checkup: Key Questions Market Players Should Be Asking (Part One)

By Covington Digital Health Team, Wade Ackerman, Nigel Howard, Daniel Pavin and Lindsey Tonsager on Posted in Data Security, Health Data, Medical Apps, Medical Devices and FDA
In the first of a three-part series, Covington’s global cross-practice Digital Health team answers key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. Key Regulatory Questions About Digital Health Solutions 1. What are … Continue Reading
LexBlog