Devices

Changes Sought on Waiver by Studies Guidance

AdvaMedDx says it appreciates what FDA has done to review and clarify its policies on study designs that can support both 510(k) and CLIA waiver applications. In comments, it notes that it also commented on a related docket on select updates for recommendations for CLIA waiver applications for manufacturers of in vitro diagnostic devices. The association says that while its proposed recommendations were aimed at the CLIA waiver guidance, they would also apply in the case where a submitter seeks a sequential 510(k) clearance followed by CLIA waiver approval. It said it is pleased to see that in its latest guidance FDA has offered an opportunity to leverage a joint study design to support such a dual submission pathway.

The Coalition for CLIA Waiver Reform says its review of the draft guidance indicates that significant changes are required, particularly for CLIA waiver evaluation. The group also recommends that FDA focus on addressing the standards with regard to CLIA waiver in the “select updates” guidance and then cross-reference that discussion in the dual submission guidance.

Finally, the BRIDGE (Bridging Real-world Insight for Device Governance and Evaluation) Coalition says it supports applying a logical and least burdensome approach to assessing applications for CLIA waivers. However, it says, the draft guidance does not discuss least burdensome considerations or options. “There is no indication that least burdensome was considered in the drafting of this guidance,” it declares. “The coalition feels that the final draft should reflect actual considerations of least burdensome with specificity. A mere recitation of least burdensome is not sufficient.”

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