Devices

Notifying CDRH About Device Shortage Guidance Update

FDA has updated a guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the Covid-19 Public Health Emergency, to further assist manufacturers in providing the agency with timely and informative notifications about changes in the production of certain medical devices that could help FDA prevent or mitigate shortages of such devices during the Covid-19 public health emergency. The document also recommends that manufacturers voluntarily provide additional details to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during the pandemic.

The guidance is effective immediately and is intended to remain in effect only during the Covid-19 public health emergency, FDA says.

An agency statement says the original guidance was updated to:

clarify factors FDA considers in determining whether a device is in shortage, how shortage assessments inform FDA work to help address the public health emergency, and what information FDA includes in the publicly-available list of medical devices FDA has determined to be in shortage;
provide information regarding letters for failing to notify FDA;
provide information about prioritizing and expediting inspections and premarket review to help mitigate and prevent shortages; and
revise the recommended timeline for updates to Section 506J notifications from two weeks to six weeks.

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