Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Roadmap” addresses continued focus on digital health, among other priorities, as one way that the agency seeks to further its public health mission and foster innovation that benefits consumers and patients.  Consistent with this focus, the agency also announced a public workshop on January 30-31, 2018, to discuss the status of its Software Pre-Cert Program, which we wrote about here.

These announcements follow a consistent drumbeat of digital health focus from FDA during 2017, including release of two draft and one final guidance documents that are intended to implement the objectives of the 21st Century Cures Act.  These include the following:

  • The Clinical and Patient Decision Support Software (CDS) Draft Guidance. As explained by FDA, this guidance “is intended to make clear what types of CDS would no longer be defined as a medical device, and thus would not be regulated by the agency. For example, generally, CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation… However, the FDA will continue to enforce oversight of software programs that are intended to process or analyze medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as these remain medical devices under the Cures Act.” The comment period is open until Tuesday, February 6, 2018.
  • The Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act Draft Guidance.  This draft guidance updates the agency’s thinking relative to exercise of jurisdiction or enforcement discretion over low risk mobile and digital health products, as previously addressed in FDA’s Mobile Medical Application and General Wellness guidance. The deadline for public comments is Tuesday, February 6, 2018.
  • The Software As A Medical Device (SaMD): Clinical Evaluation Final Guidance. This finalizes draft guidance issued in 2016 and attempts to further global regulatory harmonization efforts by establishing common principles for regulators to use in evaluating the safety, effectiveness and performance of SaMD.


Continue Reading

The “Internet of Medical Things Resiliency Partnership Act of 2017” was introduced in the House of Representative earlier this month.  Co-sponsored by Rep. David Trott (R-MI) and Rep. Susan Brooks (R-IN), the bill would require establishment of “a working group of public and private entities to develop recommendations for voluntary frameworks and guidelines to increase the security and resilience of networked medical devices sold in the United States that store, receive, access, or transmit information to an external recipient or system for which unauthorized access, modification, misuse, or denial of use may result in patient harm.”

Continue Reading

In his keynote address at the AdvaMed annual conference in late September, FDA Commissioner Scott Gottlieb returned to the themes of promoting innovation by partnering with industry.  Consistent with that, and furthering the agency’s emphasis on digital health innovation, he announced the companies that will be participating in FDA’s Pre-Cert program, a program that the agency describes as “intended to inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product.”

Continue Reading

The recent release of two guidance documents addressing current FDA enforcement policies for medical devices that are Medical Device Data Systems (MDDS) and mobile applications (mobile apps), provide further evidence that when it comes to health IT products, FDA’s policy aims to keep unnecessary FDA regulation from impeding the progress of new technologies that offer

A recent report issued by the U.S.-China Economic and Security Review Commission (USCC)[1] highlights why the Chinese market is central to the business strategy of many U.S. companies that manufacture and market pharmaceuticals, medical devices, and other healthcare products.  The Congressionally-mandated report[2], issued in November 2014, addresses in detail the opportunities and challenges surrounding

Recently, FDA released two draft guidance documents on the promotion of prescription drugs and medical devices on the Internet and social media platforms.  The long-awaited guidance provides recommendations for firms that choose to correct misinformation disseminated by independent third parties and to promote their products on space-constrained platforms, such as Twitter or sponsored ads.  Comments

The Food and Drug Administration (“FDA”) announced last week the publication of a final rule banning bisphenol-A (“BPA”) from use in infant formula packaging – a decision made based on proof of industry abandonment rather than safety concerns. In July 2012, then-U.S. Representative Edward J. Markey filed a food additive petition seeking to amend the

The use of mobile apps for health purposes has created new questions for users, developers, and regulators regarding the balance between convenience, expanded health care, and public safety. The line between apps that are useful tools for accessing health information and those that are considered medical devices can be unclear but is very important for

The House Subcommittee on Oversight and Investigations concluded a three-day series of hearings regarding medical device mobile applications (“MMAs”) on Thursday morning. Our posts regarding the first two hearings are here and here. The focus of day three was to hear testimony from key FDA and DHHS officials who have responsibilities relating to MMAs

The Health Subcommittee of the House of Representatives Energy and Commerce Committee held a second day of hearings regarding medical device mobile applications (“MMAs”) on Wednesday. Our post regarding the first day of hearings can be found here. The focus of day two was “Health Information Technologies: How Innovation Benefits Patients.”

The subcommittee heard