Devices

AdvaMed Backs Bill to Modernize Device Inspections

The Advanced Medical Technology Association (AdvaMed) says bipartisan legislation introduced 2/16 “will help modernize FDA’s inspections process through a risk-based approach that will focus the agency’s limited resources on facilities that have the most potential to impact public health, improving overall patient safety.” The bill, S. 404, was introduced by Sens. Johnny Isakson (R-GA) and Michael Bennet (D-CO).

The AdvaMed statement says that both the medical technology industry and FDA recognize the need for a robust inspections process to help ensure the continued availability of safe and effective devices and diagnostics for patients. “However,” the association says, “the agency’s current inspections process suffers from a lack of consistency, predictability, and transparency, preventing both FDA and industry from addressing quality and compliance issues in an efficient manner.”

In addition to moving inspections to a risk-based approach, AdvaMed says, the bill would also:

establish a process for companies to address deficiencies more quickly and robustly;
create a more focused and efficient inspection process for FDA;
harmonize the inspection process to eliminate regional variations; and
improve communications between FDA and companies to ensure timely implementation of any remediation plans.

AdvaMed concludes that the legislation “will lead to a higher level of patient safety and more efficient use of inspector time and effort, while not taking away any of FDA’s authority to inspect device manufacturing facilities.”

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