Contaminated eye drops present serious risks. Not only can they cause blindness and other serious medical conditions, but they have also been linked to at least four cases of premature death caused by severe bacterial...more
In one of the last proposed notices from the US Department of Health and Human Services (HHS) under the Trump administration, HHS removed the 510(k) premarket notification requirement for seven types of gloves and proposed...more
The U.S. Food and Drug Administration (FDA) extended the enforcement discretion period for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) by an additional six months, citing the challenges...more
The Situation: As medical devices become more connected to each other and to the internet, an increasing number of patients are exposed to cybersecurity risks. The Result: Over the last five years, the Food and Drug...more
On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more
With more and more medical devices connected to the Internet of Things (IoT), there is increasing concern over the potential vulnerabilities for cyberattacks against such devices. This vulnerability represents not only...more
On October 18, 2018, FDA issued a long-awaited draft revision to its existing guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"(premarket cybersecurity guidance). This coincided...more
In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the...more