Devices

FDA ‘Least Burdensome’ Guidance ‘Could Be Worse’: Attorney

Attorney Adrienne Lenz (Hyman, Phelps & McNamara) says that while industry may feel that under the FDA 2/5 final guidance on least burdensome provisions it is continually being asked for more information, data, and studies to support their devices, “the final guidance, by way of sharing examples where FDA has used least burdensome approaches, suggests that, in many cases, it could be worse.” Writing in her firm’s FDA Law Blog, Lenz says there are not many differences in the final guidance compared to the 12/2017 draft guidance.

“It can be a challenge for sponsors to know exactly what will be used in the regulatory decision making as the agency continues to request new and different information to establish a reasonable assurance of safety and effectiveness or substantial equivalence,” Lenz writes. “For 510(k)s, sponsors are required to include a signed statement that no material fact has been omitted and thus, may question whether omission of a study they performed might be problematic even if it does not seem necessary for regulatory decision making.”

Additional examples of FDA’s use of least burdensome approaches have been added, according to Lenz. She also cites several additions to the final guidance that should be welcomed by industry, and notes that readers are encouraged to interact with the agency early on so as to develop least burdensome approaches, especially in situations where their device may have or may be perceived to have different risks.

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