Devices

PMA, HDE Supplement Covid-19 Guidance

FDA has published an immediately-in-effect guidance, Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency, containing agency policy to help address current manufacturing limitations or supply chain issues due to disruptions caused by the Covid-19 public health emergency. The policy is to remain in effect only for the duration of the HHS public health emergency.

Under the guidance, FDA does not intend to object to limited modifications to the design and manufacturing of medical devices approved through either a PMA or HDE without prior submission of a PMA or HDE supplement or 30-day notice. The document says the policy applies to limited modifications to approved HDEs or PMAs that would trigger the requirement that a manufacturer submit a PMA or HDE supplement or 30-day notice to FDA. Examples of such limited modifications may include immediate changes adjusting manufacturing processes to allow for social distancing, adapting manufacturing or design due to supply chain disruption, or moving device production to a region that is less affected by Covid-19, FDA says.

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