Devices

Don’t Wait for SBOM Finalization: Fu

University of Michigan professor Kevin Fu, who was the CDRH acting director of medical device cybersecurity, says companies don’t have to wait for FDA to finalize its guidance before starting to develop and submit software bills of materials (SBOM). In an interview posted in a ReversingLabs blog, Fu says some medical device firms are doing well with SBOMs, while others could use some serious guidance.

“It’s just so important to have SBOM in medical device design for the whole reason that SBOM exists in the first place,” Fu said. “If you don’t have an ingredient list of the third-party software, how can you even begin to answer the question, what risks are we taking? What’s the residual risk? What is our plan when software starts to get out of date? You can’t even begin until you know what you have there. So it’s just so important.”

Fu referenced an FDA draft guidance on SBOMs, noting that the comment period has closed and it’s pretty clear what the agency’s thinking is. He said he does anticipate major changes to the draft.

For companies submitting a 510(k) or PMA, he said, FDA does not technically recommend an SBOM but nothing is stopping a company from submitting one, and the best companies are submitting them. “So, if you want to have smoother sailing, you don’t have to wait…. It’s just so obvious it’s going to make your life easier when you can discuss the risk not only in broad strokes but down to the individual software packages. I view SBOM actually helping with efficiency for getting things through.”

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