Drugs

Device Cybersecurity Guide Coming by 9/30: FDA

FDA is planning to finalize by 9/30 its draft guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which replaced a 2018 draft guidance on content of premarket submissions for management of cybersecurity in medical devices. If all goes as planned, the guidance will be available 10/1, which is the effective date when CDRH says it will begin issuing refuse-to-accept letters for device submissions missing required cybersecurity information that was mandated at the end of last year in the omnibus spending bill, according to CDRH Office of Strategic Partnerships and Technology Innovation director Suzanne Schwartz. “We are working very diligently in trying to get that finalized,” she said during an online govinfosecurity.com interview.

FDA said the new draft guidance was intended to “further emphasize the importance of ensuring that devices are designed securely, enabling emerging cybersecurity risks to be mitigated throughout the total product lifecycle and to outline FDA’s recommendations more clearly for premarket submission content to address cybersecurity concerns.”

According to the refuse-to-accept policy, CDRH says device submissions should include:

a plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits,
a software bill of materials, including commercial, open-source, and off-the-shelf software components

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome