Wil Henderson

Jan 14, 2025 | jdsupra.com | Robert Church |Ashley Grey |Wil Henderson

[co-author: Lauren Massie]U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product development, clinical research, and clinical care, which we summarized here.

Jul 18, 2024 | jdsupra.com | Suzanne Friedman |Wil Henderson |Komal Karnik Nigam

Below, we analyze the changes to the updated enforcement policy and provide key takeaways for entities responsible for communication regarding approved/cleared medical products. FDA’s revised draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs” clarifies a safe harbor described in the 2014 draft guidance for companies voluntarily addressing misinformation on the internet and social media.

Jul 17, 2024 | lexology.com | Suzanne Friedman |Komal Karnik Nigam |Jodi Scott |Wil Henderson |Randy Prebula

The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how firms can address misinformation about their approved medical products posted by independent third parties.

Jun 6, 2024 | jdsupra.com | Suzanne Friedman |Wil Henderson |Randy Prebula

Last month, FDA finalized its landmark proposed rule that would amend the definition of “in vitro diagnostic (IVD) products” in 21 CFR 809.3, effective May 6, 2024, to make explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA), “including when the manufacturer of the IVD is a laboratory.” In summarizing the final rule online here at the time, we predicted that litigation against the rule was likely.

Feb 7, 2024 | jdsupra.com | Wil Henderson |Michael Heyl |Lina R. Kontos

FDA has just published a 101-page rule titled “Medical Devices; Quality System Regulation Amendments,” finalizing the February 2022 proposed rule of the same name. It aims to harmonize FDA quality regulations, first developed in 1996, with the 2016 version of ISO (International Organization for Standardization) 13485, which will be incorporated by reference in the QMSR.