Devices

FDA Continues Device Supplement Guidance

FDA has issued an immediately effective guidance, Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions, saying the agency will not object to certain limited modifications within the scope of the guidance being implemented with a retrospective update in the next periodic report. The document supersedes one issued during the Covid-19 public health emergency in 5/2020 that was updated in 5/2022.

Examples of allowable modifications cited in the guidance are:

design and manufacturing changes to address component unavailability due to supply chain disruptions;
manufacturing changes to allow an establishment to maintain operations and accommodate social distancing in appropriate situations based on local conditions;
changes in manufacturing facility or establishment; and
changes to packaging procedures.

While the policy originally was intended to address Covid-19 issues, FDA says its experience has generally demonstrated that the public health equities weigh in favor of exercising certain enforcement policies for the submission of certain PMA and HDE supplements beyond a 180-day extension after the expiration of the official Covid-19 public health emergency, which expired on 5/11.

“FDA has evaluated the benefits and risks to patients and healthcare providers of exercising certain enforcement policies including identifying certain device modifications for which enforcement policies might be appropriate, and assessing other lessons learned from implementation of Covid-19-related enforcement policies for certain device modifications,” the guidance says. “FDA has continued to observe supply chain challenges and shortages of medical devices remain widespread. Although this guidance has been revised to remove any expiration date for the enforcement policy, FDA intends to continue to monitor the situation and may make further revisions to the guidance, withdraw the guidance, or pursue other regulatory actions, as appropriate.”

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