In the waning days of 2022, Congress passed the omnibus spending legislation to provide funding for the federal government through September 2023. The legislation contains numerous reforms focused on FDA bundled under Title...more
On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more
Last week, the U.S. Food and Drug Administration (FDA) issued a safety communication to remind patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in...more
This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials conducted under an approved (or conditionally approved) investigational...more
On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as...more
On December 27, 2016, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement...more
The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more
The US Food and Drug Administration (FDA or the Agency) issued draft guidance on June 18 about assessing the benefits and risks for Investigational Device Exemption (IDE) applications. The draft guidance provides a...more
On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more
The FDA recently released three warning letters that it previously issued to two health care providers relating to prescription drug and medical device clinical trials. The letters, sent in late 2013 and early 2014, detail...more
In its proposed update to the Physician Fee Schedule for calendar year 2014, the Centers for Medicare & Medicaid Services (CMS) suggested major revisions to its regulations governing Medicare coverage of investigational...more