Category: FDA and Regulatory

The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

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Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show no sign of slowing, as the number and type of medical device products that are connected to the cloud increase (thereby increasing the attack surface for hackers), and as hackers become more sophisticated. Indeed, in a September 2022 FBI Private Industry Notification, the FBI noted that around 53% of connected medical devices and other internet of things (IoT) devices in hospitals had known critical vulnerabilities. These vulnerabilities could allow hackers to direct medical devices to give inaccurate readings, administer drug overdoses, or otherwise endanger patient health.

In the past, the U.S. Food & Drug Administration (FDA) has urged manufacturers to take measures to ensure the cybersecurity of their products through non-binding guidance. On December 29, 2022, President Biden signed into law the $1.7 trillion Omnibus Appropriations Act, which provided the FDA with authority to require manufacturers to take cybersecurity protection measures as to medical devices that are brought to market through future pre-market submissions. See H.R. 2617 (117th Congress, 2021-2022), text available here.

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FDA Warns Companies about Processing, Distributing and Marketing Unapproved Stem Cell Products

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The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing, and marketing of allegedly unapproved stem cell products derived from birth-related products, such as placentas, amniotic tissues, umbilical cords, and umbilical cord blood.

These products, which include human cells, tissue, and cellar and tissue-based products (also known as HCT products) are intended to treat a variety of orthopedic issues, autism, cardiac issues, dementia and arthritis. HCT products are considered “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” Examples of HCT products include “bone, ligament, skin, dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, epithelial cells on a synthetic matrix, and semen or other reproductive tissue.”

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FDA Warns Against Sales Representative’s “False and Misleading” Oral Statements Regarding Prescription Medicine

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The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Eisai Inc. on October 11, 2018, based on a sales representative’s “false and misleading” oral statements during a lunch presentation about the safety of the antiepileptic medication Fycompa®, downplaying warnings, and engaging in off-label promotion of the product.

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