Devices

Two Device Guides on CLIA Waivers

FDA has issued two final guidances to help device makers that seek Clinical Laboratory Improvement Amendments (CLIA) waivers for certain products. The first guidance, Recommendations for Dual 510(k) and CLIA Waiver by Application Studies, is intended to assist manufacturers in using the agency’s dual 510(k) and CLIA waiver by application pathway. It describes study designs for generating data that may support both510(k) clearance and a CLIA waiver. FDA believes this pathway is the least burdensome and fastest approach for manufacturers to obtain both a CLIA waiver and 510(k) clearance for new in vitro diagnostic (IVD) tests.

The second guidance, Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices, describes recommendations for device manufacturers seeking to submit information through a CLIA waiver application to FDA to support a determination whether the device meets CLIA statutory waiver criteria. The document includes FDA’s revised thinking on the “appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.” It also provides additional approaches for demonstrating that a test meets the waiver criteria.

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