Devices

FDA Cybersecurity 2022 Guidance Explained

Attorney Brynn Stanley(Gardner Law) says medical device manufacturers should start planning and implementing the concepts found in an FDA April draft guidance on cybersecurity in both their products and within their quality management system. Writing in an online post, Stanley says that to be effective, cybersecurity needs to be “baked in” and not “bolted on.”

She says the 2022 draft guidance, which replaced a 2018 guidance, emphasizes the importance of ensuring that devices are designed securely and are capable of mitigating emerging cybersecurity risks throughout the total product lifecycle (TPLC). “This change to a TPLC approach,” Stanley writes, “will impact manufacturers as they begin to incorporate these concepts into not only their premarket submissions, as was the focus of the 2018 draft guidance, but also into their design controls processes. In fact, effects of the TPLC approach will be felt throughout a manufacturer’s quality management system. This is likely to have a big impact on manufacturers, especially for those with legacy products or for companies playing ‘catchup’ to the 2018 draft guidance.”

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

Read more

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