Archives: Medical Devices and FDA

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FDA Regulation of mHealth Updates

At the Food Drug and Law Institute’s annual conference on April 21, 2015, Bakul Patel, Associate Director for Digital Health, Office of Center Director, Center for Devices and Radiological Health (CDRH), held a discussion of “FDA Regulation of Mobile Health/Medical Applications.”  As we discussed in a previous post (see here), there have already been several … Continue Reading

The Cyber Future of Long-Term Care: Applying Health Care Laws to Aging in Place Technologies

Earlier this month, the National Law Journal published its annual Special Report on Health Care Law. Included in this Special Report is an article written by CovingtonEHealth contributors Caroline Brown, Anna Kraus, and Phil Peisch, entitled, The Cyber Future of Long-Term Care: Applying Health Care Laws to Aging in Place Technologies. This article explores how … Continue Reading

Upcoming Webinar: Regulation of eHealth Products and Mobile Apps (February 25, 2015)

As part of Covington’s ongoing Life Sciences Essentials webinar series, we will be presenting a program on Regulation of eHealth Products and Mobile Apps on February 25, 2015 (12:30-2:00 p.m. EST). Our panelists, including two alumni of the FDA Office of Chief Counsel, will address: What factors determine whether an eHealth product is considered a medical device … Continue Reading

Important Developments in FDA Regulation of Software, Including Mobile Apps

This year is set to bring several important developments from Congress and FDA relating to FDA regulation (or deregulation) of software, including mobile apps. FDA has recently issued several draft and final guidances in this space and Congress has circulated several draft bills. Most recently, the House Energy and Commerce Committee released a discussion draft … Continue Reading

FDA Publishes Draft Guidances Describing General Wellness Claims and Risk-Based Classification of Accessories

Our colleague and contributor Cassie Scherer just published a post on the InsideMedicalDevices blog analyzing today’s FDA draft guidances on the Center for Devices and Radiological Health’s (CDRH) policy regarding low risk general wellness products and regulation of medical device accessories.  Although the guidances are not solely focused on software, they provide further clarification to the rapidly developing and expanding mobile app and … Continue Reading

Welcome to Covington eHealth

While Covington eHealth is a new publication, lawyers at Covington & Burling LLP have been writing on topics related to eHealth for many years, including on other Covington blogs. Below is a selection of eHealth-related articles posted to other Covington blogs in the first half of 2014. We encourage you to visit our other sites … Continue Reading

FDA Issues Long-Awaited Draft Guidance Documents Concerning Internet/Social Media

Our colleagues at the InsideMedicalDevices blog have posted a short summary of two draft guidance documents recently issued by the FDA pertaining to internet/social media.  The first draft guidance document discusses how manufacturers of drugs, biological products, and medical devices should respond to misinformation about their products posted by third parties on internet/social media platforms.  The second document focuses … Continue Reading

FDA Releases FDASIA Health IT Report With Recommendations for a Risk-Based Regulatory Framework

On April 3, 2014, the Food and Drug Administration (“FDA”) proposed a risk-based approach to determining the level of oversight that should apply to health information technology (“HIT”).  The FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework divides HIT into three functional categories that pose varying levels of safety risks and … Continue Reading

Mobile Health in the United States and China

Last week, the Center for Technology Innovation at the Brookings Institution presented a paper and hosted a panel discussion on how mobile technology can decrease the cost and improve the quality of health care in the United States and China.  The presenters noted, however, that significant policy and legal challenges face the telemedicine industry in … Continue Reading

Legal and Practical Challenges Surround Telehealth Implementation

Health care providers and other entities face a host of legal and practical challenges as they implement telehealth and telemedicine initiatives. For example, providers of telehealth services, and the entities creating or hosting telehealth platforms, must determine which federal and state privacy and security laws apply to them.  These laws, such as the federal Health … Continue Reading

Lawmakers and Biotechnology Industry Organization Press OMB to Release E-Labeling Rules

In recent weeks, two sets of stakeholders have urged the Office of Management and Budget (OMB) to release the Food and Drug Administration’s (FDA) proposed rule on e-labeling, “Electronic Distribution of Prescribing Information of Human Prescription Drugs,” 0910-AG18.  On January 22, 2014, the Biotechnology Industry Organization issued a letter urging OMB and FDA to issue … Continue Reading
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