Devices

FDA Explains Covid-19 Test Guidance

A 3/2 CDRH Webinar explained the FDA guidance on policy for diagnostics testing in laboratories certified to perform high complexity testing under CLIA prior to emergency use authorization (EUA) for coronavirus disease during the public health emergency. On the program, Office of Product Evaluation and Quality director of the Office of In Vitro Diagnostic and Radiologic Health Timothy Stenzel said the guidance was issued 2/29 and took effect immediately because the agency determined that with the Covid-19 public health emergency it was not feasible or appropriate to seek prior public participation.

The guidance describes a policy regarding certain laboratories immediately using tests they have developed and validated to achieve a more rapid testing capacity in the U.S., Stenzel said.

The policy is limited to laboratories certified to perform high complexity testing consistent with the requirements under the Clinical Laboratory Improvement Amendment (CLIA). It is for molecular diagnostics under the SARS-COV-2 virus. The guidance does not affect requirements under CLIA, Stenzel said, and does not affect CDC recommendations for who should be tested.

The document includes recommendations on validating newly-developed coronavirus tests before clinical use, notifying FDA when clinical use of a validated test begins, confirming the first five positive and negative samples with EUA authorized tests, indicating in test reports that the test has been validated but independent FDA review is not complete, submitting EUA within 15 days of initiating testing, and steps to take if any specimen fails confirmatory testing or if FDA is unable to authorize the EUA. It also has recommendations on the minimal testing to be performed for validation.

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