Devices

Changes Sought in Establishment Inspection Guidance

AdvaMed says an FDA draft guidance on review and update of device establishment inspection processes and standards “should be risk-based and consider the participation of the subject company in international device audit programs.” The trade association’s 5/28 comment letter also recommends that the draft guidance include criteria to assist agency investigators in maintaining uniform processes and standards, and that agency procedures should include metrics to measure success of the revised inspection processes.

When FDA extended the comment period on the draft guidance, AdvaMed submitted an additional comment asking that the agency clarify the guidance to provide that the FDA Reauthorization Act of 2017 mandate that it implement consistent processes and standards for inspection of medical device establishments applies to inspection of any device or device component of a combination product, regardless of which Center has jurisdiction over the device.

Abbott’s letter specifically asks that FDA clarify applicability of the document to devices subject to BLAs.

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