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The health care industry is increasingly adopting mobile apps for a variety of purposes, including tracking patient health conditions and sharing patient data. Privacy and security are important considerations, and it is...more
On September 28, 2022, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited final guidance, “Clinical Decision Support Software” (the “Final CDS Guidance”). The Final CDS Guidance supersedes...more
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more
It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12...more
Since the start of the COVID-19 pandemic, more people than ever have downloaded and used mobile applications, or apps, to communicate with their doctors, manage prescriptions, and streamline much of the healthcare activity...more
Type I Diabetes is the most common type of diabetes in children, impacting about 1 in 400 children in the US according to the American Diabetes Association. Children diagnosed with Type 1 diabetes require lifelong daily...more
CMS is soliciting comments on whether future payments for devices that may have been impacted by the COVID-19 PHE should be adjusted. The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related...more
On July 28, the U.S. Food and Drug Administration (FDA) issued the final guidance “Multiple Function Device Products: Policy and Considerations,” which describes FDA's regulatory approach and policy for products with multiple...more
On Wednesday, July 15, the House Energy and Commerce (E&C) Committee advanced several bills to the House floor that demonstrate continued interest in health policy matters other than the COVID-19 pandemic. The Fairness in...more
The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more
The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more
On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more
Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more
On December 6, 2018, Commissioner Scott Gottlieb announced the FDA’s highly anticipated new strategic framework for assessing the potential use of real-world evidence (RWE) in connection with the agency’s drug and biologic...more
Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more
On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more
FDA recently issued a final guidance on the Refuse to Accept Policy for 510(k)s (Guidance). The Guidance outlines the procedures and criteria FDA uses to determine whether a medical device premarket notification (510(k))...more
The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain. The...more
• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions. • The...more
Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...more
On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more
On December 7, 2017, the US Food and Drug Administration (FDA) published a highly anticipated draft guidance document that describes how the agency intends to exercise oversight over clinical decision support (CDS) software....more
The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA...more
FDA recently issued a draft guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers”, which is intended to bring clarity to a specific provision in...more
On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more