Tag Archives: Software

FDA Releases Digital Health Innovation Action Plan and Initiates Software Pre-Certification Pilot Program

In two new posts on the Covington Digital Health blog we analyze the Digital Health Innovation Action Plan recently released by FDA and the agency’s new software pre-certification (Pre-Cert) pilot program. The Digital Health Innovation Action Plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes and modernizing [the agency’s] … Continue Reading

CFDA Releases Draft Classification Catalogue of Medical Devices

The China Food and Drug Administration (CFDA) has recently released a long-anticipated draft Classification Catalogue of Medical Devices (Draft Catalogue). The Draft Catalogue updates a 2002 Classification Catalogue (Current Catalogue) and is one of the final pieces in the reform of China’s medical device system that has taken place since the 2014 revision of the … Continue Reading

eHealth and mHealth Software Classification Changes in Forthcoming EU Medical Device Regulation

The new EU Medical Devices Regulation (MDR), a draft of which was tentatively agreed by the EU’s legislators on June 15, 2016, was revised at the last minute to include a new classification rule for software. Software’s classification under the MDR will determine its regulatory treatment (including what requirements it has to meet, and what … Continue Reading

Is Medical Software a Medical Device? European Court of Justice to Decide

On June 13, 2016, the French Conseil d’État (supreme administrative court) referred to the EU Court of Justice (“CJEU”), the question of whether medical software that provides support to healthcare professionals in prescribing medicinal products should be considered a medical device under Directive 93/42 (the “Directive”) (Case C-329/16).  The qualification of software as a medical … Continue Reading

FDA Finalizes General Wellness Guidance

Last week FDA finalized a guidance document entitled “General Wellness: Policy for Low Risk Devices” in which the agency sets forth an approach to not regulate “general wellness products.”  This guidance document is important to the rapidly growing market for wellness products, which includes such things as activity trackers, smart watches, mobile apps, and other … Continue Reading

FDA Releases Draft Guidance on the Use of EHRs in Clinical Investigations

On May 17, 2016, FDA issued draft guidance encouraging clinical investigators to make their electronic data capture (“EDC”) systems interoperable with health care organizations’ electronic health records (“EHRs”).  Although EHRs are generally under the control of health care organizations and institutions (not FDA-regulated entities such as sponsors), when records are used in clinical investigations, FDA … Continue Reading

FDA Finalizes Guidance Limiting Oversight of Certain Software Devices

On February 9, 2015, FDA issued a final guidance document “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” in which the agency finalized a deregulatory policy for certain software devices.  FDA’s new guidance document largely confirms the enforcement policies set forth in the draft guidance document FDA issued in July … Continue Reading

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

FDA published two much anticipated draft guidances on January 16, 2015, which outline the Center for Devices and Radiological Health’s (CDRH) policy regarding low risk general wellness products and regulation of medical device accessories.  Although not solely focused on software, these guidances provide further clarification to the rapidly developing and expanding mobile app and software … Continue Reading

FDA Finalizes Guidance for Management of Cybersecurity in Medical Devices

The U.S. Food and Drug Administration (“FDA”) has increasingly focused on promoting cybersecurity because compromised medical devices can pose a risk to patient health as well as the confidentiality of personal medical information.  On October 2, 2014, FDA issued final guidance on the content of premarket submissions for the management of cybersecurity in medical devices.  … Continue Reading

FDA Relaxes Regulation of Certain Software Devices

On June 20, 2014, FDA issued a draft guidance entitled “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” informing manufacturers and others “that the Agency does not intend to enforce compliance with the regulatory controls” that apply to these three types of devices. Medical device data systems (MDDS), medical image … Continue Reading

New UK Guidance on Software as a Medical Device

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on software as a medical device, including apps.  The guidance aims to assist those working in healthcare, and software developers, to determine whether a specific piece of stand-alone software or an app constitutes a medical device.  The MHRA provides illustrative examples of software, … Continue Reading

FDA Launches OpenFDA To Ease Access to FDA Datasets — Which Creates Opportunities for Developers of Mobile Medical Apps

Last week, FDA launched openFDA­—its new, open government initiative.  Created in response to an executive order on transparency, openFDA will provide access to many of the agency’s health data sets.  FDA is encouraging developers of websites and mobile medical apps to process FDA’s health data so it is more useful for the public, clinicians, and … Continue Reading

International Consensus on “Software as Medical Device” Definition

Last December, the International Medical Device Regulators Forum (IMDRF) reached a consensus on a potentially key aspect of the future regulation of medical software in the US, the EU, Brazil, Canada, and Japan, that is, a harmonized definition of when stand-alone software will be considered to be a medical device. This category of software, dubbed … Continue Reading

Key Open Questions for FDA’s Upcoming Report on Regulation of Health IT

We’ve previously blogged about the “FDASIA Workgroup” and section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which directed FDA to issue a report to Congress by January of 2014 on the regulation of health technology.  This post covers some of the differing views on Health IT regulatory issues and open … Continue Reading

House to Consider Bill Excluding Clinical and Health Software from Regulation as Medical Devices

On October 22, Rep. Marsha Blackburn (R-TN) introduced a bill serving to “provide for regulating medical software, and for other purposes” in the House of Representatives.  The bill, entitled the Sensible Oversight for Technology which Advances Regulatory Efficiency (“SOFTWARE”) Act (“the bill”), was co-sponsored by a bi-partisan group of lawmakers.… Continue Reading

FDA Releases Final Mobile Medical Apps Guidance

On Monday, FDA released a final version of its guidance document, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff.    The guidance describes FDA’s approach for regulating certain mobile applications (apps) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Although the final guidance retains the basic framework of the … Continue Reading

FDASIA Workgroup Releases Draft Recommendations for Regulation of Health IT

FDA’s regulation of Health IT under its medical device authorities can be seen as proceeding on two separate tracks during the last year. Track one is FDA’s ongoing policymaking.  In 2011, FDA issued a draft guidance document on mobile medical applications and a final rule on medical device data systems, setting forth an approach for … Continue Reading

FDA Issues Draft Guidance Document on Cybersecurity in Medical Devices

The issue of cybersecurity has been on FDA’s radar in the last year, due in part to a Government Accountability Office report issued last August that urged FDA to consider the risk of intentional threats to device information security.  Although the GAO report noted that FDA was not aware of any actual incident of device … Continue Reading

Lessons from FDA’s First Public Mobile Medical Apps Enforcement Letter

As we discussed in a previous post, FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies.  The letter received extensive media coverage, and the mHealth sector was immediately abuzz with interest (and concern) … Continue Reading

FDA Takes First Public Mobile App Enforcement Action

FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies.  Although FDA reportedly has approached app developers in the past about obtaining 510(k) clearances for their products, this is the first time that FDA … Continue Reading

Growth in the Wearable Sensor Market Puts New Focus on Difficult Regulatory Questions

Big news came out of the digital health industry this week, when Jawbone announced that it would acquire BodyMedia, reportedly for more than $100 million.  Both companies market products in a rapidly growing sector of the digital health industry:  wearable sensors that track and analyze users’ lifestyles.  Jawbone’s UP can track sleep, movement, and diet, … Continue Reading

FDA Issues Draft Guidance on Molecular Diagnostic Instruments with “Combined Functions” That Reflects Regulatory Creep

On April 9, 2013, FDA published a Federal Register notice announcing a new draft guidance on molecular diagnostic instruments with “combined functions” — i.e., combining functions subject to FDA approval or clearance as well as functions not subject to FDA approval or clearance (such as research use only (RUO)).  The draft guidance has significant implications … Continue Reading

New UK Guidance for Doctors on Prescribing Medical Devices and Medicines

The General Medical Council in the UK has issued new prescribing guidance for doctors that includes detailed provisions on prescribing medical devices and managing patients using medical devices. The GMC’s previous guidance was focused almost exclusively on medicines.  The new guidance recognizes that medical devices — particularly software-based devices and remote monitoring devices — are … Continue Reading
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