Devices

Integrate Cybersecurity in Medical Device Reviews: OIG

The HHS Inspector General (IG) says FDA should promote use of presubmission meetings to address cybersecurity-related questions, include cybersecurity documentation as a criterion in the agency’s Refuse-to-Accept checklist, and include cybersecurity as an element in its “Smart” template. The recommendations are in a study report that notes that cybersecurity is an area with increasing risk to patients and the healthcare industry as more medical devices use wireless, Internet, and network connectivity.

The IG analysts found that FDA reviews the cybersecurity documentation in premarket submissions that manufacturers submit to the agency before the devices can be marketed. Agency reviewers look for cybersecurity documentation in company submissions, the report says. At the time of the study, FDA had almost always cleared or approved the cybersecurity aspect of networked medical devices because manufacturers had been able to respond with supplemental cybersecurity information that FDA deemed sufficient.

“FDA could further integrate cybersecurity into its overall review process,” the report concludes. “FDA’s ‘Refuse-to-Accept’ checklists, which the agency uses to screen submissions for completeness, do not include checks for cybersecurity information. Also, FDA’s ‘Smart’ template, which FDA uses to guide its reviews of submissions, does not prompt FDA reviewers with specific cybersecurity questions that they should consider and also lacks a dedicated section for recording the results of the cybersecurity review.” The report says the agency concurred with the IG’s three recommendations.

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