Devices

Covid PMA or HDE Supplement Guidance

FDA has issued 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, to provide a policy to help address current manufacturing limitations or supply chain issues due to disruptions caused by the Covid-19 public health emergency. The document applies to limited modifications affecting the safety or effectiveness of a device approved through the PMA programs that would trigger the requirement that a manufacturer submit a PMA supplement or 30-day notice to FDA under the regulations.

The policy also applies to limited modifications affecting the safety or probable benefit of a device approved through the HDE program that would trigger the requirement that a manufacturer submit an HDE supplement or 30-day notice to FDA.

The guidance says examples of such modifications may include, but not be limited to:

design and manufacturing changes to address component unavailability due to supply chain disruptions;
manufacturing changes to allow the establishment to maintain operations and accommodate social distancing practices;
changes in manufacturing facility or establishment; and
changes to packaging procedures.

The policy does not apply to design or manufacturing changes made for reasons other than addressing manufacturing limitations or supply chain issues resulting from the Covid-19 emergency or any proposed changes described in a regulatory submission already received by FDA.

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