Devices

CDRH Prefers Guidance Comments in Table Format

CDRH says it prefers public comments on its guidance documents that are submitted in a “table format” because it facilitates the Center’s analysis and compilation of comments received. This preference is suggested in a new CDRH Web page on “Tips for Submitting Comments on CDRH Guidance Documents.” The table format tip suggested that these can be provided in a document or spreadsheet, and it included an example to reference.

CDRH says stakeholder comments are “critical to the guidance development process and help us ensure our recommendations meet stakeholder needs.” It says comments should be concise and clear, and that proposing revised or additional language is also appreciated. “Include a reference to the section(s) of the guidance the comment is intended to address; inclusion of line numbers is preferred,” it says. “Include an explanation to ensure that CDRH is able to understand and better assess the comment.” Additionally, it recommends to not repeat the same comment multiple times within a comment response for the same 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

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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