Expanded Information Block Rules Go into Effect
Podcast: Interoperability: The Provider Perspective - Diagnosing Health Care
Podcast–Interoperability: How Far We’ve Come and Where We’re Going - Diagnosing Health Care
The New Information Blocking Rule: What It Means For Hospices
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
In FDA regulatory matters, companies must carefully choose when to challenge the government, and when to comply. In a recent case, Whoop, the Boston-based wearable maker, has chosen to openly challenge the U.S. Food and Drug...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
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
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
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
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
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
Key Points - - Although the Cures medical software provisions largely align with FDA's current policies, certain of the Cures exemptions may be broader than those under current agency policy. - Many clinical...more
The 21St Century Cures Act, Pub. L. No. 114-255, 130 Stat. 1033, was signed into law on December 13, 2016. This expansive statute addresses topics ranging from investigational drug clinical trial design, mental health...more